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Memorial Blood Centers Hospital Resource Guide
Memorial Blood CentersA Division of Innovative Blood Resources
We create trusted and innovative solutions to help our customers achieve their goals
Rev. June 2015 Table of Contents • Page iiMBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Table of Contents
Introduction 1About this Hospital Resource Guide 1
Updates 1We invite your comments 1
About Memorial Blood Centers, A Division of Innovative Blood Resources 2Who We Serve 3How We Do What We Do 4
Right Production, Right Type 4
A Service Culture Designed to Meet all of your Hospital’s Needs 5We’re Here When You Need Us 6
By Phone 6On the Web 6
Routine Ordering and Delivery 7Routine Orders 7STAT and ASAP Orders 7
Definitions: 7
Ordering Policy 7Supply Orders 7Routine Ordering and Delivery Times 7
Saint Paul 7Duluth 7
Ordering Special Components 8Modified Components 8
Transportation of Blood Components 9Memorial Blood Centers-Central (MBCM) 9Memorial Blood Centers-Duluth (MBCD) 10Delivery Services 11
Blood Hub Use 12Blood Hub Screen Examples 12, 13Routine Order Form 14
Handling, Storage and Return 15Handling and Storage of Blood Components 15
Receiving Blood and Components 15Packing Lists 15Manual Packaging List 16Blood Component Return Guidelines 17
Guidelines for Storage of Blood and Blood Components 18, 19Memorial Blood Centers Policy 18Example Record of Return/Transfer 19
Transferring Units 19, 20Transferring Units to Another Memorial Blood Centers Facility 19Transferring Units with a Patient to: 20Hospitals Memorial Blood Centers Does Not Service 20
Inventory Reconciliation 20Guidelines for Returning and Packing of Red Blood Cells 20Guidelines for Packing Platelets 20
Shipping Box 21
Rev. June 2015 Table of Contents • Page iiiMBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Product Codes 22Memorial Blood Centers Transfusable Blood Product Codes Manufactured at MBC 22
Whole Blood 22Frozen RBC 22Non-Leukoreduced RBC 23–24Leukoreduced RBC 24-27Apheresis Platelets 27-28Platelet from Whole Blood 29Pooled Platelets 29Plasma 29-30
Memorial Blood Centers Testing Catalog 31Donor Testing Laboratory 31
Viral Screening, Red Cell Typing, Nucleic Acid Testing 31–39
Quality Assurance 41Physician Services and Quality and Regulatory Affairs 41Quarantine, Market Withdrawal, Recall, Inventory Lookback and Recipient Notification 41
If you are notified of a market withdrawal or recall, it is imperative that you: 41
Reporting Adverse Outcomes of Transfusion 41Communications 42
Customer Service Reports: 42
Quality Control (QC) of Blood Components 43Serious Outcome of Transfusion Report 43Suspected Transfusion Transmitted Disease Report 44
Reference Laboratory 45Request for Antibody Identification and Red Cell Crossmatching 45Unit Antigen Typing 45Antibodies in Donors 45Platelet Crossmatching 45HLA Matched Platelets 46Service Fees 46Request for Reference Lab Testing 47
Guidance for Industry 48-54Qualifications Letter 55
Memorandum 55
Parentage Testing 56Common Questions & Answers 56
Why should you choose Memorial Blood Centers? 56How can I start testing for a parentage dispute? 56What type of testing is available? 56At what age are children able to be tested? 56What type of sample is collected from the individuals tested? 56How long does the collection take? 56Is there a difference in accuracy between a blood and buccal swab sample? 57Are these tests accurate? 57How long will it take to get results? 57Will the child and/or mother need to be re-collected if the first man is excluded? 57Can tests be performed when the parties involved live in different states or countries? 57If an Alleged Father is deceased can paternity testing still be done? 57Is the accuracy of a DNA test affected by drug use, illness or disease? 57
Parentage Testing Services 58Service Fees 58
Rev. June 2015 Table of Contents • Page ivMBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Routine Trios (Mother, Child & Alleged Father) 58Family Studies (Motherless, Fatherless, Grandparents, Siblings, Y-chromosome, etc ) 58Special Testing 58Additional Fees 58Expert Witness 58
Educational Opportunities 59Department of Training and Education 59American Association of Blood Banks (AABB) Audioconferences/ American Society for Clinical Pathology (ASCP) Teleconferences 59Student Rotations 59Facility Tours 59Volunteer Opportunities 59Continuing Education 59Current Topics and Controversies in Transfusion Medicine 59Reference Laboratory Workshops 59School Presentations 60“My Blood, Your Blood” 60Technical Advisory Meeting (TAM) 60Medical Advisory Council 60
Testing Services 61Thank You 63Addendum 64
Special Collections 64
Rev. June 2015 Introduction • Page 1MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Introduction
OverviewMemorial Blood Centers is honored to be your healthcare partner. And we are committed to ensuring that you have the resources you need to perform at your best as you provide the essential services that save and sustain lives. This Hospital Resource Guide, provided exclusively to our valued hospital partners, has been created to help streamline the delivery of our services to you and most effectively support you in your work. It is an important reference that details our operating policies, procedures, and practices.
Please keep this resource guide in a convenient place and use it as an easy-to-access tool to help answer questions you might have. Additional information also can be quickly accessed at our website: MBC.ORG/Products-and-Testing-Services. In addition, feel free to contact Hospital Services for more information at 651-332-7108 (Metro) or 218-740-1520 (Northland).
UpdatesFrom time to time, the information contained in this Hospital Resource Guide may change or become outdated. When appropriate, Memorial Blood Centers will issue updates. Please be aware that it is the hospital’s responsibility to ensure it has the most current information and that the updated pages or sections are added and old pages are discarded.
If you are unsure if this guide contains the most current updates, please call Hospital Services for clarification or visit our website at MBC.ORG.
We invite your comments. Memorial Blood Centers strives to provide you with the best customer service possible and we welcome your thoughts and ideas about this Hospital Resource Guide. If there is important information you would like to see included or other ways we can effectively keep you up-to-date on operational changes, please feel free to contact us at 651-332-7108 (Metro) or 218-740-1520 (Northland).
This Hospital Resource Guide is provided for the exclusive use of Memorial Blood Centers’ hospital partners. Any other distribution or use is strictly prohibited.
About this Hospital Resource Guide
Rev. June 2015 Introduction • Page 2MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
About Memorial Blood Centers, A Division of Innovative Blood Resources
Who we areMemorial Blood Centers has been saving and sustaining lives for over 65 years. A Minnesota-based, independent nonprofit, we supply life-saving blood, state-of-the-art laboratory services, and biomedical expertise to area hospital and clinic partners, national blood centers, biotechnology companies, research institutions, and international clients from Australia to Switzerland.
As a mission-driven organization committed to advancing the cause of blood donation and ensuring the health and well-being of all of our citizens, in 2012 Memorial Blood Centers formalized a decade-long partnership with Nebraska Community Blood Bank (NCBB) of Lincoln, NE to form a new blood services organization. Our two community-based non-profits now operate as divisions of the newly formed entity: Innovative Blood Resources. Both are 501(c)(3) not-for-profit, charitable organizations. Each is licensed by the FDA and accredited by AABB and CLIA.
While we will continue doing business as (d/b/a) Memorial Blood Centers, all blood products collected by MBC and NCBB and shipped to our hospital partners will be labeled with the Innovative Blood Resources name.
Learn more about:Innovative Blood Resources at InnovativeBloodResources.org Memorial Blood Centers at MBC.ORG Nebraska Community Blood Bank at NCBB.ORG
Mission | To help save lives by providing blood and biomedical services
Rev. June 2015 Introduction • Page 3MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Who We Serve
As a division of Innovative Blood Resources, Memorial Blood Centers provides a comprehensive menu of blood products, laboratory services, and technical expertise to a diverse client base of over 40 partner hospitals in Minnesota, Nebraska and Wisconsin—from large, multi-unit systems to government-run Level 1 trauma centers, to tertiary hospitals and rural facilities. Additionally, we serve dozens of laboratory and blood bank customers across the United States, including the Mayo Clinic and the National Marrow Donor Program (Be The Match), and provide blood products for special manufacturing around the globe.
As a national blood provider with a local focus on community participation to advance our mission of saving lives through blood donation, we service customers with core competencies in production planning, blood utilization management, advanced Immunohematology Reference Laboratory services, and internationally-recognized transfusion medicine expertise. Visit our website at MBC.ORG/About-Us/Service-Area for a current list of hospital partners.
Blood Products
Reference Lab
Donor Testing
International
Vision | To delight our customers and be the best blood center in America
Rev. June 2015 Introduction • Page 4MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
How We Do What We Do
With hospitals as our most valuable partners, our work at Memorial Blood Centers comes full circle: from donor to recipient.
Our core work processes connect people to people. Beginning with generous donors, Memorial Blood Centers’ systematic, robust processes help us achieve our ultimate goal: meeting patients’ needs 100% of the time by delivering the life-saving blood to our hospital partners that recipients need whenever, wherever it is needed most.
Right production, right type— readily available at the right time
Sophisticated production planning, effective screening and manufacturing, excellent forecasting, and deployment of leading-edge technology ensure that Memorial Blood Centers efficiently meets each hospital’s unique specifications. As a result, we have built a solid reputation for dependability, reliability, and service excellence with local, regional, and national clients.
A two-time Minnesota Quality Award winner recognized for our commitment to continuous improvement and customer service, Memorial Blood Centers maintains safety and quality at the highest levels possible while streamlining processes and maximizing cost-efficiencies to deliver competitively-priced blood products.
Donors
Production Planning
Recruitment
Collections
Testing
Manufacturing
Distribution
Recipients
Strategic Approach | We create trusted and innovative solutions to help customers achieve their goals
Rev. June 2015 Introduction • Page 5MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
A service culture designed to meet all of your hospital’s needs With a 65-year legacy of serving the needs of hospitals large and small, CAH and PPS partners alike, Memorial Blood Centers has become the Partner-of-Choice for hospitals that demand:
• reliable availability and 24/7 convenience• easy online ordering and comprehensive testing
services• transfusion support for cost-effective blood
management• in-service training programs for hospital staff• flexibility, agility, and creative solutions to meet
unique requirements In addition to providing a comprehensive menu of blood products, Memorial Blood Centers is a nationally-recognized leader in advanced laboratory testing. Our FDA-licensed and EU-compliant advanced laboratory facilities provide a full range of testing services to help ensure a safe and stable blood supply that protects donors and recipients, while research advances the scientific study of infectious diseases that set the standard for the blood industry.
• Decades of experience performing more than 3 million blood sample tests for clients, including reproductive medicine providers, national and regional blood centers, the National Marrow Donor Program, and such world-renowned facilities as the Mayo Clinic
• AABB-accredited Immunohematology Reference Laboratory
• HPC-Hematopoietic Progenitor Cell Lab accredited by AABB and The Foundation for the Accreditation of Cellular Therapy (FACT)
• Partner of the American Rare Donor Program
FDA registered | AABB Accredited | CLIA Licensed
Visit MBC.ORG/About-Us/Accreditations to view all current accreditations.
Rev. June 2015 Introduction • Page 6MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
We’re here when you need us
By Phone:
Key Contacts - Metro
General Information 1-888-GIVE-BLD (888-448-3253) 651-332-7000
Hospital Services 651-332-7108 Phone651-332-7004 Fax651-490-9431 Cell
Hospital Services & Lab Relations Manager
651-332-7109
Key Contacts - NorthlandGeneral Information 218-723-8080
Duluth Hospital Services 218-740-1520 Phone218-740-1521 Fax218-591-3813 Cell
Component Services Manager 218-740-6125
Additional Contact Information
Billing/Invoice Questions Accounts Receivable
651-332-7252
Donor & Patient Testing 651-332-7119
Reference Laboratories 651-332-7125
Associate Medical Director and Director, Physician Services Elizabeth Perry, M.D.
651-332-7285
Medical Director and VP, Medical & Regulatory Affairs Jed Gorlin, M.D.
651-332-7284
On the Web:
MBC.ORG/Products-and-Testing-Services/Products-and-Testing-Services-Overview
Rev. June 2015 Routine Ordering and Delivery • Page 7MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Routine Ordering and Delivery
Routine Orders
Routine orders for blood and/or components are made by accessing the Memorial Blood Centers website www.mbc.org and logging into the Blood Hub Online Ordering System. Each Transfusion Services employee will be entered into the Blood Hub system by the Memorial Blood Centers Hospital Services Designee or the Transfusion Services assigned administrator for your facility. Blood Hub will send the user an email with a link to set their own password. Passwords are required to be changed every 90 days. (See example of login screen on page 12.)
As a back-up to the Blood Hub Online Ordering System, Memorial Blood Centers will provide a paper copy of the Fax Order Form. The Fax Order Form should be used only when the Blood Hub System is not functioning. (See example on page 14.)
For technical difficulties with Blood Hub, we request that you contact a Memorial Blood Centers Hospital Services Designee or the Transfusion Services assigned administrator for your facility.
For reasons of inventory management, Memorial Blood Centers reserves the right to ship ABO compatible components in lieu of the specific requested type. If Memorial Blood Centers requests that a substitution be made, the charge will reflect the component of lesser cost.
STAT and ASAP Orders
The Hospital Services Department is staffed 24 hours, 7 days a week at the Saint Paul location and the Duluth location. To place a STAT/ASAP order, log on to Blood Hub and place your order. All STAT and ASAP phone orders must be followed-up with a submitted order through Blood Hub or via fax.
Definitions:• STAT — Orders are for an emergency need,
shipped in 1 hour once the component is available.• ASAP — Orders are shipped in less than 4 hours
once the component is available.• Routine — Orders are sent with the next scheduled
delivery to your facility, or in less than 24 hours.• Specialty Orders — Reference Lab requests can be
placed through Blood Hub. • Memorial Blood Centers-Central (MBCM)• Memorial Blood Centers-Duluth (MBCD)
Ordering Policy
Full-Service Hospitals recognize that Memorial Blood Centers is the primary source for blood and blood components. Specifically, Memorial Blood Centers maintains a sufficient inventory to meet hospital needs. In the event that Memorial Blood Centers does not have sufficient inventory, Memorial Blood Centers will contact other blood centers to obtain the blood and blood components needed. If Memorial Blood Centers cannot meet the hospital’s need within the time frame requested, the hospital may contact another blood center or non-affiliated hospitals to obtain the required blood and/or blood components.
Supply Orders
Supplies can be ordered through Blood Hub or the fax order form if Blood Hub is not functioning. For a complete listing of supplies available from Memorial Blood Centers, refer to the current service fees.
Routine Ordering and Delivery Times
Saint Paul
Day Order Time Delivery TimeMonday – Friday Morning Orders
6:30 am to 8 am 9 am to 10:30 am
8 am to 9 am 10:30 am to Noon
Monday – Friday Afternoon Orders
2 pm to 4 pm 4:30 pm to 7:30 pm
Saturday and Sunday By 9 am 9:30 am to 1 pm
Duluth
Day Order Time Delivery TimeMonday – Friday 7:00 am to 9 am 10 am to 11:30 am
Stock Rotation for Duluth Facilities
Stock rotation occurs every 1–3 weeks for some affiliate sites on predetermined dates. The hospital rotates older stock units back to Memorial Blood Centers-Duluth in return for fresher units.
note: Duluth area hospitals located out of town that are served by Memorial Blood Centers should communicate with the Duluth Hospital Services staff when ordering blood/components that are not part of their routine exchange. These orders should be placed early enough for Memorial Blood Centers to arrange a routed courier service. Please contact Duluth Hospital Services for delivery time frame.
Rev. June 2015 Routine Ordering and Delivery • Page 8MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Ordering Special Components
Modified ComponentsTo order modified components place the order using Blood Hub or the Fax Order Form can be used when Blood Hub is not functioning. Because modification of blood components can be a time consuming process for the blood center, please consider this when placing the order to ensure timely delivery. The expiration date for most modified components is shortened, which must also be considered prior to placing an order. Refer to the table below for approximate modification times and new expiration dates.
Special Component Requests
Component Description
*Approximate Preparation Time
New Expiration Date
Availability
Washed Red Cell Unit (MBCM only)
1.5 hours 24 hours M – F, 7 am –10 pm
Other times: on call charges apply
Deglycerolized Red Cell Unit (MBCM only)
2 hours 24 hours M – F, 7 am –10 pm
Other times: on call charges apply
Washed Platelet Component (MBCM only)
2.5 hours 4 hours M – F, 7 am –10 pm
Other times: on call charges apply
Irradiation of Components 15 minutes 28 days or unit expiration (whichever is shorter)
24 hours a day, 7 days a week
Volume Reduction of Platelets 1 hour 4 hours M – F, 7 am –10 pm
Other times: on call charges apply
If unit must be pooled prior to volume reduction — add 30 minutes
Sterile Connection of Pediatric/Transfer Bags
30 minutes NA M – F, 7 am –10 pm
Other times: on call charges apply
Add 30 minutes if requesting Memorial Blood Center to divide into transfer bags
Antigen Negative Unit Dependent upon antigen requested and inventory levels
NA Refer to Reference Laboratory section
Preparation time does not include transportation time to the hospital.
For requests during non-routine hours an additional one hour must be added to preparation time. Call Hospital Services to inquire about preparation times for any components not listed above.
Rev. June 2015 Routine Ordering and Delivery • Page 9MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Transportation of Blood Components
• Memorial Blood Centers works together with each hospital to select an appropriate delivery schedule to meet the Hospital’s inventory needs.
• Memorial Blood Centers provides routine deliveries at no charge according to an established schedule.
• Charges for additional deliveries, requested by the Transfusion Services, are the responsibility of the requesting Hospital.
Memorial Blood Centers-Central (MBCM)Serving the Twin Cities Metro Area and Southern Minnesota
Telephone number: 651-332-7108Cell number: 612-490-9431Fax number: 651-332-7004Hours of Operation: 24 hours a day
Orders Routine Non-RoutineRequest Restocking Online ordering – see “Ordering Section”
for current schedule cut-offCentral Business Hours: 24 hours a day, 7 days a week
Call MBCM Hospital Services and place order through Blood Hub, the online ordering system.
Inventory Exchange Standing Order
NOTE: Orders not received by the cutoff will be shipped with the next scheduled routine delivery. If needed earlier, the delivery charges are the responsibility of the requesting Hospital.
Delivery Schedule Monday – Friday 2 deliveries daily STAT — Request processed immediately shipped <1 hour once product is availableSaturday, Sunday, and
Holidays1 delivery daily
ASAP — Request shipped < 4 hours once product is availableInventory Exchange Every 1–3 weeks as scheduled
Delivery Charge No Charge Requesting facility pays delivery fees.
Transportation fees are billed monthly by MBC
Highway Patrol: The highway patrol is available ONLY for Critical Medical Emergency transport.
The order MUST be ready for pick-up when the Highway Patrol arrives at the sending site — communication and coordination between the sender and the receiver is crucial.
Rev. June 2015 Routine Ordering and Delivery • Page 10MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Memorial Blood Centers-Duluth (MBCD)Serving Duluth, Northern Minnesota and Wisconsin
Telephone number: 218-740-1520Cell number: 218-591-3813Fax number: 218-740-1521Hours of Operation: 24 hours a day
Orders Routine Non-RoutineRequest Restocking Online ordering by 7:30 am. Our
earliest courier leaves at 8:00 am.Duluth Business Hours: 24 hours a day, 7 days a week
Call MBCD Hospital Services or place order through Blood Hub.
Inventory Exchange Every 1–3 weeks as scheduled
NOTE: Orders not received by the cutoff will be shipped with the next scheduled routine delivery. If needed earlier, the delivery charges are the responsibility of the requesting Hospital.
Delivery Schedule Monday – Friday 1 delivery daily STAT — Request processed immediately shipped <1 hour once product is available
Inventory Exchange Every 1–3 weeks as scheduled ASAP — Request shipped < 4 hours once product is available
Delivery Charge No Charge Requesting facility pays delivery fees.
Transportation fees are billed monthly by MBC
Highway Patrol: The highway patrol is available ONLY for Critical Medical Emergency transport.
The order MUST be ready for pick-up when the Highway Patrol arrives at the sending site — communication and coordination between the sender and the receiver is crucial.
Transportation of Blood Components (continued)
Rev. June 2015 Routine Ordering and Delivery • Page 11MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Delivery Services
Carrier Telephone # Service Area ServiceMemorial Blood Centers -Central 651-332-7108 Twin Cities Metro Area, Southern/
Northern Minnesota• Routine• ASAP• STAT
Memorial Blood Centers - Duluth 218-740-1520 Duluth, Northern Minnesota and Wisconsin
• Routine• ASAP• STAT
Couriers Hybrid 612-308-7667 Twin Cities and Duluth • Routine• ASAP• STAT• Scheduled
Quicksilver 651-484-1111 Twin Cities • Routine• ASAP• STAT
MedStat 763-586-0369 Twin Cities • Routine• ASAP• STAT
Velocity Express 218-726-1514 Duluth Area • ASAP• STATScheduled Routes in Duluth Region
ZOOM 218-348-1144 Duluth Area • Routine• ASAP• STAT• Scheduled
Northern Lights 218-729-5841 Duluth Area Scheduled Routes in Duluth Region
Cab Red & White 612-871-1600 Twin Cities • Routine• ASAP• STAT
Allied 218-722-3311 Duluth Area • ASAP• STAT
Orders must be placed with a minimum of 2 hours prior to published departure times
Other Greyhound Statewide Call MBC-Central for schedule
Delta United States
Midnight Express United States
Skyline skylineshuttle.com
Shuttle from Duluth to St. Paul and airport Call MBC-Duluth
Fed-Ex United States Place order before 4 pm for next day delivery. Sat. delivery available
Rev. June 2015 Routine Ordering and Delivery • Page 12MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Blood Hub Use
See Blood Hub training presentation and Blood Hub How to Guide links on the Blood Hub Dashboard page for full instructions for use.
Example of the Blood Hub Log in Screen
Select the Products you are ordering, blood types, and quantities
Verify that your order is correct
Complete your order
Rev. June 2015 Routine Ordering and Delivery • Page 13MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Example for placing an antigen screened order
Note: An Antigen Screened order includes units that will be tagged and have antigens confirmed
Note: Do not select Antigen Screened to request “Historical” typed antigens – place a regular order for those and type “Historical” in the comment field
Click the Create Order Link, select Antigen Screened, and Shipping Options
Blood Hub allows you to place an order and tell us the Date/Time when the order is needed. Select Delivered by Date/Time under shipping options to use this feature.
Select Products, Blood Types, and Quantities. Then select the antigens to screen for
Verify the order for accuracy Complete the Order
Rev. June 2015 Routine Ordering and Delivery • Page 14MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Rev. June 2015 Handling, Storage and Return • Page 15MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Handling, Storage and Return
Handling and Storage of Blood Components
Receiving Blood and ComponentsUpon receipt of a shipment of blood and/or blood components it is imperative that the receiving facility:
1. Ensure the blood and/or blood components have arrived at your facility at the proper temperature:Product Shipping Temperature • Red Blood Cells 1 – 10o C• Platelets 20 – 24o C +/-2o C• Frozen Components Dry ice must be present
2. Compare the unit numbers and components on the packing list against the actual numbers/components received.
3. Visually inspect each unit received according to your hospital policies and American Association of Blood Banks (AABB) guidelines.
note: Contact Hospital Services immediately if a discrepancy or problem is noted. If not contacted in writing within 10 days of receipt of shipment, your facility assumes responsibility for each component listed on the original packing list.
Packing ListsYour facility will receive a packing list with each shipment of blood and/or blood components. The packing list contains a listing of each component contained within the shipment. There is also a listing of historical antigen typing for each red cell unit (refer to Page 45 for a description of antigen testing). The person at your facility who receives the shipment should sign the packing list. Signed packing lists should be maintained at your facility in accordance with AABB and Food and Drug Administration (FDA) guidelines.
In the event that the computer system at Memorial Blood Centers is not functional and/or a component must be sent to your facility as an emergency release, you will receive a handwritten manual packing list. The manual packing list must be treated as your official packing list (as in the paragraph above).
Examples of a computer-generated and a manual packing list are provided below and on the following page.
Rev. June 2015 Handling, Storage and Return • Page 16MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Rev. June 2015 Handling, Storage and Return • Page 17MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Blood Component Return Guidelines
These guidelines were developed to:
• Encourage judicious inventory management practices by Memorial Blood Centers and each of our customers for the benefit of all customers served.
• Allow hospitals to establish their own criteria for managing their unique patient populations and sharing in the cost of meeting their inventory needs
Any component issued by Memorial Blood Centers with a ‘shorted-dated’ sticker will not be charged to the hospital if the unit outdates at the hospital.
Discard unit, report disposition and request credit on Hospital Request Credit Report (Form-IT-005). Send Hospital Request Credit Report to your distribution hub by the last day of the month. Credit requests received late will be posted to the next month’s billing cycle. Policies/Guidelines are monitored for effectiveness in inventory management and financial outcomes; changes are made as necessary.
Modified components (washed, irradiated, volume reduced, etc.) are not acceptable for return and credit will not be issued with the exception of Irradiated Red Cell Components. Irradiated Red Cells are acceptable for return if they meet the guidelines listed below.
JobAid-HS-002.9 05/13
Rev. June 2015 Handling, Storage and Return • Page 18MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Component GuidelinesPlatelet Apheresis — Reserved for a specific patient (by hospital request — yellow sticker):
HLA-Matched Special Typing (PIA1) Cross-matched
Sent to hospital when available
Charged to hospital if not used
If used by alternate hospital — collection fee of $250 plus special fees (HLA, cross-matching, irradiation), charged to requesting hospital; receiving hospital charged $250
All fees associated with units imported to meet a patient’s specific need are passed on to the hospital.
Platelet Concentrates
Returns accepted with > 48 hours to expiration
If < 48 hours, (day of expiration), contact Hospital Services, St. Paul. If unit can be used, no charge, if it cannot be used, hospital will be charged
Frozen Plasma Components > 3 months to outdate — may be returned
Components not available at Memorial Blood Centers
Memorial Blood Centers physician consulted for alternative
If hospital chooses not to use suggested alternative, hospital charged full cost of imported component.
If no alternative, Memorial Blood Centers assumes cost of imported alternative.
Guidelines for Storage of Blood and Blood Components
Memorial Blood Centers PolicyAll full-service hospitals served by Memorial Blood Centers may return blood components with an accompanying Record of Return Transfer form The return form must be generated in Blood Hub or the facilities own computer system (if the computer system generates a pre-approved return packing slip).. Units not acceptable for reissue will be charged to the hospital unless previous arrangements for credit have been made. The following conditions apply to any hospital returning blood components to Memorial Blood Centers:
• The hospital must store all blood and blood components according to current AABB and FDA guidelines
• A Record of Return Transfer packing slip generated by Blood Hub (see the example below) or the Hospitals computer system must be included
with each return shipment. If Blood hub is not functioning a Record of Return/Transfer paper copy (Form-HS-020) (See example on page 19) may be used as long as it is completely filled out. Each unit returned must be listed on the return form individually with a return reason clearly documented.
• The Record of Return Transfer form MUST be completed by an employee of the hospital Transfusion Service to indicate that the blood and/or blood components have been stored continuously as directed on the unit label.
notes: • Memorial Blood Centers will NOT accept units for
return without a return reason and the initials of the person shipping the units.
• The return packing slip generated in Blood Hub will document the tech, date and time of return and will require checking an acceptance box indicating that the units are acceptable for return for reissue.
Blood Hub generated return form below.
Rev. June 2015 Handling, Storage and Return • Page 19MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Paper copy of Return/Transfer form (Form-HS-020)
An example of a Record of Return/Transfer form (Form HS-020) is provided. Record of Return/Transfer forms are provided free of charge. If you need forms, call Hospital Services and they will be sent with a routine order.
Component Description
Storage Temperature
Comments
Platelet Component 20 – 24o C Continuous agitation is required
Buffy Coats 20 – 24o C DO NOT AGITATE
Red Blood Cells 1 – 6o C
Frozen Component < -18o C
NOTE: These storage guidelines are provided to assist your facility in the proper storage temperature for components. It is the responsibility of your facility to follow all applicable storage regulations provided by the AABB and FDA.
Transferring Units
Transferring Units to Another Memorial Blood Centers FacilityWhenever possible, components should be returned to Memorial Blood Centers for transfer to another facility. However, if it becomes necessary to expedite the delivery, you may be asked to transfer blood and/or blood components directly to another facility. To do this:
• Arrange for transportation from your facility to the hospital needing the blood and/or components. Hospital Services may assist you in this effort, if necessary call them directly.
• Complete the Record of Transfer in Blood Hub or the facilities Computer system and indicate which facility the units were transferred to. A paper generated Record of Return/Transfer form may be used if Blood Hub is not functioning (see example on page 18.
• Notify Hospital Services by fax or phone that the units were transferred.
• Instruct the receiving facility to complete the Record of Return Transfer upon receipt of the shipment and forward to Hospital Services.
Rev. June 2015 Handling, Storage and Return • Page 20MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Transferring Units with a Patient to:Hospitals Memorial Blood Centers ServicesIf the blood and/or blood components are transferred with a patient to a hospital supplied by Memorial Blood Centers:
• A Record of Return Transfer form must be completed
• The blood and/or components must be received at the proper storage temperature by the receiving facility
NOTE: If the receiving facility will NOT accept the units, it is your responsibility to charge the patient for the units. Memorial Blood Centers will charge your facility (original receiving facility) for these units.
Hospitals Memorial Blood Centers Does Not ServiceIt is sometimes necessary to transport units with a patient to a hospital Memorial Blood Centers does not service. Blood and/or blood components may be transferred to these facilities at your discretion.
Memorial Blood Centers hospitals that send blood and/or blood components to hospitals that Memorial Blood Centers does not serve will be charged for the units. It is then up to you to charge the receiving hospital appropriately.
These blood components may not be returned to any hospital Memorial Blood Centers serves or to Memorial Blood Centers itself. The sending hospital is responsible for billing the receiving hospital for all units involved. Please contact Hospital Services with questions.
Inventory Reconciliation
FDA and AABB Standards require that it be possible to trace any unit of blood or component from source (the donor or the collecting facility) to final disposition (transfused, shipped, and/or discarded).
Memorial Blood Centers uses several different processes to meet this requirement:
• Memorial Blood Centers will involve Transfusion Services in a periodic reconciliation of physical inventories and inventory records.
• Transfusion Services staff is responsible for assisting Memorial Blood Centers staff in the reconciliation of any discrepancies.
• Transfusion Services may be asked to provide final disposition information to Memorial Blood Centers to complete the blood center records.
• Each Transfusion Service is responsible for developing processes to comply with this requirement.
Guidelines for Returning and Packing of Red Blood Cells
Memorial Blood Center’s standard shipping box with Styrofoam inserts should be used in combination with gel packs, which have been frozen at approximately -18oC.
Please refer to JobAid-HS-015.1 How to Pack Red Blood Cells for Return which is distributed to hospital customers. Call Hospital Services department management if you do not have this JobAid at your facility.
Guidelines for Packing Platelets
1. Memorial Blood Center’s standard shipping box with the Styrofoam inserts may be used only for routine in town shipments, which are expected to be less than 2 hours, when outside temperatures are between 40oF and 85oF.
2. Memorial Blood Center’s platelet shipping container with molded foam sides can be used for any platelet shipment and should be used for platelet shipments expected to take >2 hours or when outside temperature are >85oF or <40oF.
Rev. June 2015 Handling, Storage and Return • Page 21MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Memorial Blood Centers Standard Shipping Box
1. Place 1 additional Styrofoam sheet on the bottom of the shipping box
2. Ensure plastic liner is inside the shipping box
3. Place 1 three pound room temp gel pack on the bottom of the box
4. Place component(s) on top of the gel pack
5. Place 1 additional three pound gel pack on the top of the component(s)
6. Wrap plastic liner securely around the components(s)
7. Place 2 Styrofoam sheets on the top of the gel packs
Memorial Blood Centers Platelet Shipping Box
1. Ensure plastic liner is inside the shipping box
2. Place 1 three pound room temp gel pack on the bottom of the box
3. Place components(s) on top of the gel pack
4. Place 1 additional three pound gel pack on the top of the component(s)
5. Wrap plastic liner securely around the component(s)
6. Place foam insert on the top of the units and gently push to secure
Rev. June 2015 Product Codes • Page 22MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Product Codes
Memorial Blood Centers Transfusable Blood Product Codes Manufactured at MBC
Whole BloodMBC Code
ISBT Product Code
Product Description
THER B0009 Whole Blood Therapeutic Draw (component is created and discarded)
E0052 E0052 WHOLE BLOOD|CPD/XX/refg|LowVol:anticoag not adj
E0130 E0130 WHOLE BLOOD|CP2D/XX/refg|LowVol:anticoag not adj
E4150 E4150 WHOLE BLOOD|CPD/XX/refg|LowVol:anticoag adj
E4152 E4152 WHOLE BLOOD|CPDA-1/XX/refg|LowVol:anticoag adj
E4153 E4153 WHOLE BLOOD|CP2D/XX/refg|LowVol:anticoag adj
E5013 E5013 WHOLE BLOOD|CPD/XX/refg|Irradiated|LowVol:anticoag not adj
E5014 E5014 WHOLE BLOOD|CPD/XX/refg|Irradiated|LowVol:anticoag adj
E5015 E5015 WHOLE BLOOD|CPDA-1/XX/refg|Irradiated|LowVol:anticoag not adj
E5016 E5016 WHOLE BLOOD|CPDA-1/XX/refg|Irradiated|LowVol:anticoag adj
E5120 E5120 WHOLE BLOOD|CPDA-1/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag not adj
E5121 E5121 WHOLE BLOOD|CPDA-1/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag adj
E5559 E5559 WHOLE BLOOD|CP2D/XX/refg|Irradiated|LowVol:anticoag adj
E5560 E5560 WHOLE BLOOD|CPD/XX/refg|ResLeu:<5log6|LowVol:anticoag adj
E5561 E5561 WHOLE BLOOD|CP2D/XX/refg|ResLeu:<5log6|LowVol:anticoag adj
E5562 E5562 WHOLE BLOOD|CPD/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag adj
E5563 E5563 WHOLE BLOOD|CP2D/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag adj
E5564 E5564 WHOLE BLOOD|CP2D/XX/refg|Irradiated|LowVol:anticoag not adj
E5565 E5565 WHOLE BLOOD|CPD/XX/refg|ResLeu:<5log6|LowVol:anticoag not adj
E5566 E5566 WHOLE BLOOD|CPDA-1/XX/refg|ResLeu:<5log6|LowVol:anticoag not adj
E5567 E5567 WHOLE BLOOD|CP2D/XX/refg|ResLeu:<5log6|LowVol:anticoag notadj
E5568 E5568 WHOLE BLOOD|CPD/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag not adj
E5569 E5569 WHOLE BLOOD|CP2D/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag not adj
WB2 E0112 WHOLE BLOOD|CP2D/500mL/refg
WB2I E0120 WHOLE BLOOD|CP2D/500mL/refg|Irradiated
WBI* E0031 WHOLE BLOOD|CPD/500mL/refg|Irradiated
WB* E0023 WHOLE BLOOD|CPD/500mL/refg
E5612 E5612 WHOLE BLOOD|CPDA-1/XX/refg|ResLeu:<5log6|LowVol:anticoag adj
Frozen RBCMBC Code
ISBT Product Code
Product Description
FZ E5079 Frozen RED BLOOD CELLS|None/XX/<-65C|Open
FZD E4520 Deglycerolized RED BLOOD CELLS|None/XX/refg|Open
FZDI E4522 Deglycerolized RED BLOOD CELLS|None/XX/refg|Open|Irradiated
FZI E5081 Frozen RED BLOOD CELLS|None/XX/<-65C|Open|Irradiated
RFZ* E5171 Frozen Rejuvenated RED BLOOD CELLS|None/XX/<-65C|Open
RFZI* E5176 Frozen Rejuvenated RED BLOOD CELLS|None/XX/<-65C|Open|Irradiated
RFZD* E5174 Deglycerolized Rejuvenated RED BLOOD CELLS|None/XX/refg|Open
RFZDI* E5180 Deglycerolized Rejuvenated RED BLOOD CELLS|None/XX/Refg|Open|Irradiated
Rev. June 2015 Product Codes • Page 23MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Non-Leukoreduced RBCMBC Code
ISBT Product Code
Product Description
PC1 E0316 RED BLOOD CELLS|CPD>AS1/500mL/refg
PC1I E0331 RED BLOOD CELLS|CPD>AS1/500mL/refg|Irradiated
PC2* E0262 RED BLOOD CELLS|CP2D/500mL/refg
PC2I* E0273 RED BLOOD CELLS|CP2D/500mL/refg|Irradiated
PC3* E0366 RED BLOOD CELLS|CP2D>AS3/500mL/refg
E0375 Red Blood Cells, CP2D, AS-3, Leukoreduced, Syringe Aliquot (suffix indicated as A0, B0, Ba, Bb, Bc, Bd, etc.)
E0372 Red Blood Cells, CP2D, AS-3, Leukoreduced, Syringe Aliquot, Irradiated (suffix indicated as A0, B0, Ba, Bb, Bc, Bd, etc.)
PC3I* E0378 RED BLOOD CELLS|CP2D>AS3/500mL/refg|Irradiated
PCA E0212 RED BLOOD CELLS|CPDA-1/500mL/refg
PCAI E0223 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated
PCC* E0167 RED BLOOD CELLS|CPD/500mL/refg
PCCI* E0178 RED BLOOD CELLS|CPD/500mL/refg|Irradiated
PCW E5160 Washed RED BLOOD CELLS|None/XX/refg|Open
PCWI E5168 Washed RED BLOOD CELLS|None/XX/refg|Open|Irradiated
PED1 E0212 RED BLOOD CELLS|CPDA-1/500mL/refg
PED1I E0223 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated
PED2 E0212 RED BLOOD CELLS|CPDA-1/500mL/refg
PED2I E0223 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated
PED3 E0212 RED BLOOD CELLS|CPDA-1/500mL/refg
E0605 Apheresis Red Blood Cells, CP2D, AS-3, Non-Leukoreduced
E0693*** E0693 Apheresis Red Blood Cells, CP2D, AS-3, Non-Leukoreduced, Bag 1
E0694*** E0694 Apheresis Red Blood Cells, CP2D, AS-3, Non-Leukoreduced, Bag 2
PED3I E0223 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated
PED4 E0212 RED BLOOD CELLS|CPDA-1/500mL/refg
PED4I E0223 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated
PED5 E0212 RED BLOOD CELLS|CPDA-1/500mL/refg
PED5I E0223 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated
B0018 B0018 RBC/CPD/500ml/refg/open/plasma reduced
B0019 B0019 RBC/CPD/500ml/refg/open/plasma reduced/irradiated
E0244*** E0244 RED BLOOD CELLS|CPDA-1/XX/refg|LowVol:anticoag not adj
E0283*** E0283 RED BLOOD CELLS|CP2D/XX/refg|LowVol:anticoag not adj
E0463*** E0463 RED BLOOD CELLS|CPD>AS1/XX/refg|LowVol:anticoag not adj
E0465*** E0465 RED BLOOD CELLS|CP2D>AS3/XX/refg|LowVol:anticoag not adj
E4154*** E4154 RED BLOOD CELLS|CPDA-1/XX/refg|LowVol:anticoag adj
E5247*** E5247 RED BLOOD CELLS|CPDA-1/XX/refg|Irradiated|LowVol:anticoag adj
E4155*** E4155 RED BLOOD CELLS|CP2D/XX/refg|LowVol:anticoag adj
E4156*** E4156 RED BLOOD CELLS|CPD>AS1/XX/refg|LowVol:anticoag adj
E4157*** E4157 RED BLOOD CELLS|CP2D>AS3/XX/refg|LowVol:anticoag adj
E5249*** E5249 RED BLOOD CELLS|CP2D>AS3/XX/refg|Irradiated|LowVol:anticoag adj
E5017*** E5017 RED BLOOD CELLS|CPD/XX/refg|LowVol:anticoag not adj
E5018*** E5018 RED BLOOD CELLS|CPD/XX/refg|LowVol:anticoag adj
E5067*** E5067 RED BLOOD CELLS|CPD/XX/refg|Irradiated|LowVol:anticoag not adj
E5070*** E5070 RED BLOOD CELLS|CPD>AS1/XX/refg|Irradiated|LowVol:anticoag not adj
E5071*** E5071 RED BLOOD CELLS|CPD>AS1/XX/refg|Irradiated|LowVol:anticoag adj
E5161*** E5161 RED BLOOD CELLS|CPD/XX/refg|Irradiated|LowVol:anticoag adj
E5246*** E5246 RED BLOOD CELLS|CPDA-1/XX/refg|Irradiated|LowVol:anticoag not adj
E5247*** E5247 RED BLOOD CELLS|CPDA-1/XX/refg|Irradiated|LowVol:anticoag adj
E5248*** E5248 RED BLOOD CELLS|CP2D>AS3/XX/refg|Irradiated|LowVol:anticoag not adj
Rev. June 2015 Product Codes • Page 24MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Non-Leukoreduced RBCMBC Code
ISBT Product Code
Product Description
E5249*** E5249 RED BLOOD CELLS|CP2D>AS3/XX/refg|Irradiated|LowVol:anticoag adj
E5553*** E5553 RED BLOOD CELLS|CP2D/XX/refg|Irradiated|LowVol:anticoag adj
E5557*** E5557 RED BLOOD CELLS|CP2D/XX/refg|Irradiated|LowVol:anticoag not adj
E5671 E5671 RBC/CPDA-1/500ml/refg/open/plasma reduced
E5672 E5672 RBC/CPDA-1/500ml/refg/open/plasma reduced/irradiated
E5673 E5673 RBC/CPD/500ml/refg/open/plasma reduced/plasma added
E5674 E5674 RBC/CPD/500ml/refg/open/plasma reduced/irradiated/plasma added
E5675 E5675 RBC/CPDA-1/500ml/refg/open/plasma reduced/plasma added
E5676 E5676 RBC/CPDA-1/500ml/refg/open/plasma reduced/irradiated/plasma added
AR1* E4534 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|1st container
AR1I E4529 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|Irradiated|1st container
AR1W E4566 Washed Apheresis RED BLOOD CELLS|None/XX/refg|Open|1st container
AR1WI E4562 Washed Apheresis RED BLOOD CELLS|None/XX/refg|Open|Irradiated|1st container
AR2* E4535 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|2nd container
AR2I E4530 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|Irradiated|2nd container
AR2W E4567 Washed Apheresis RED BLOOD CELLS|None/XX/refg|Open|2nd container
AR2WI E4563 Washed Apheresis RED BLOOD CELLS|None/XX/refg|Open|Irradiated|2nd container
E0150 E0150 RED BLOOD CELLS|CPD/450mL/refg
E0161 E0161 RED BLOOD CELLS|CPD/450mL/refg|Irradiated
E0195 E0195 RED BLOOD CELLS|CPDA-1/450mL/refg
E0206 E0206 RED BLOOD CELLS|CPDA-1/450mL/refg|Irradiated
E0245 E0245 RED BLOOD CELLS|CP2D/450mL/refg
E0256 E0256 RED BLOOD CELLS|CP2D/450mL/refg|Irradiated
E0291 E0291 RED BLOOD CELLS|CPD>AS1/450mL/refg
E0306 E0306 RED BLOOD CELLS|CPD>AS1/450mL/refg|Irradiated
E0341 E0341 RED BLOOD CELLS|CP2D>AS3/450mL/refg
E0356 E0356 RED BLOOD CELLS|CP2D>AS3/450mL/refg|Irradiated
E0385 E0385 RED BLOOD CELLS|CPD>AS5/450mL/refg
E0397 E0397 RED BLOOD CELLS|CPD>AS5/450mL/refg|Irradiated
E0467*** E0467 RED BLOOD CELLS|CPD>AS5/XX/refg|LowVol:anticoag not adj
E0676*** E0676 Apheresis RED BLOOD CELLS|CP2D>AS3/XX/refg|Irradiated|1st container
E0677*** E0677 Apheresis RED BLOOD CELLS|CP2D>AS3/XX/refg|Irradiated|2nd container
E0693 E0693 Apheresis RED BLOOD CELLS|CP2D>AS3/XX/refg|1st container
E0694 E0694 Apheresis RED BLOOD CELLS|CP2D>AS3/XX/refg|2nd container
E5250*** E5250 RED BLOOD CELLS|CPD>AS5/XX/refg|Irradiated|LowVol:anticoag not adj
E5251 E5251 RED BLOOD CELLS|CPD>AS5/XX/refg|Irradiated|LowVol:anticoag adj
E4158 E4158 RED BLOOD CELLS|CPD>AS5/XX/refg|LowVol:anticoag adj
E4541*** E4541 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg|Irradiated|1st container
E4542*** E4542 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg|Irradiated|2nd container
E4546*** E4546 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg|1st container
E4547*** E4547 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg|2nd container
PC5* E0404 RED BLOOD CELLS|CPD>AS5/500mL/refg
PC5I* E0419 RED BLOOD CELLS|CPD>AS5/500mL/refg|Irradiated
Leukoreduced RBCMBC Code
ISBT Product Code
Product Description
BC E3732 LEUKOCYTES|CPD/500mL/rt
Rev. June 2015 Product Codes • Page 25MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Leukoreduced RBCMBC Code
ISBT Product Code
Product Description
BCA1 E3742 LEUKOCYTES|CPDA-1/500mL/rt
BCA1I E5552 LEUKOCYTES|CPDA-1/500mL/rt|Irradiated
BCI E5551 LEUKOCYTES|CPD/500mL/rt|Irradiated
LAR1 E4532 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|ResLeu:<5log6|1st container
LAR1A E4532 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|ResLeu:<5log6|1st container
LAR1AI E4527 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|Irradiated|ResLeu:<5log6|1st container
LAR1B E4532 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|ResLeu:<5log6|1st container
LAR1BI E4527 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|Irradiated|ResLeu:<5log6|1st container
LAR1I E4527 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|Irradiated|ResLeu:<5log6|1st container
LAR1W E4564 Washed Apheresis RED BLOOD CELLS|None/XX/refg|Open|ResLeu:<5log6|1st container
LAR1WI E4560 Washed Apheresis RED BLOOD CELLS|None/XX/refg|Open|Irradiated|ResLeu:<5log6|1st container
LAR2 E4533 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|ResLeu:<5log6|2nd container
LAR2A E4533 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|ResLeu:<5log6|2nd container
LAR2AI E4528 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|Irradiated|ResLeu:<5log6|2nd container
LAR2B E4533 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|ResLeu:<5log6|2nd container
LAR2BI E4528 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|Irradiated|ResLeu:<5log6|2nd container
LAR2I E4528 Apheresis RED BLOOD CELLS|ACD-A>AS1/XX/refg|Irradiated|ResLeu:<5log6|2nd container
LAR2W E4565 Washed Apheresis RED BLOOD CELLS|None/XX/refg|Open|ResLeu:<5log6|2nd container
LAR2WI E4561 Washed Apheresis RED BLOOD CELLS|None/XX/refg|Open|Irradiated|ResLeu:<5log6|2nd container
E4543 E4543 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg/Leu:<5log6
E4538 E4538 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg|Irradiated|ResLeu:<5log6
E4544 E4544 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg/Leu:<5log6/|1st container
E4539 E4539 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg|Irradiated|ResLeu:<5log6|1st container
E4545 E4545 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg/Leu:<5log6/|2nd container
E4540 E4540 Apheresis RED BLOOD CELLS|ACD-A>AS3/XX/refg|Irradiated|ResLeu:<5log6|2nd container
E4144 E4144 Washed Apheresis RBC/none/xx/refg/open/ResLeu:<5log6
E4145 E4145 Washed Apheresis RBC/none/xx/refg/open/Irradiated/ResLeu:<5log6
LPC1 E0336 RED BLOOD CELLS|CPD>AS1/500mL/refg|ResLeu:<5log6
LPC1I E0332 RED BLOOD CELLS|CPD>AS1/500mL/refg|Irradiated|ResLeu:<5log6
LPC2* E0276 RED BLOOD CELLS|CP2D/500mL/refg|ResLeu:<5log6
LPC2I* E0274 RED BLOOD CELLS|CP2D/500mL/refg|Irradiated|ResLeu:<5log6
LPC3* E0382 RED BLOOD CELLS|CP2D>AS3/500mL/refg|ResLeu:<5log6
LPC3I* E0379 RED BLOOD CELLS|CP2D>AS3/500mL/refg|Irradiated|ResLeu:<5log6
E0678 Apheresis Red Blood Cells, CP2D, AS-3, Leukoreduced (Single collection)
E0661 Apheresis Red Blood Cells, CP2D, AS-3, Leukoreduced, Irradiated (Single collection)
E0685*** E0685 Apheresis Red Blood Cells, CP2D, AS-3, Leukoreduced, Bag 1
E0668** E0668 Apheresis Red Blood Cells, CP2D, AS-3, Leukoreduced, Irradiated (Single collection)
E0686*** E0686 Apheresis Red Blood Cells, CP2D, AS-3, Leukoreduced, Bag 2
E0669*** E0669 Apheresis Red Blood Cells, CP2D, AS-3, Leukoreduced, Bag 2, Irradiated
LPCA E0226 RED BLOOD CELLS|CPDA-1/500mL/refg|ResLeu:<5log6
LPCAI E0224 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated|ResLeu:<5log6
LPCC* E0181 RED BLOOD CELLS|CPD/500mL/refg|ResLeu:<5log6
LPCCI* E0179 RED BLOOD CELLS|CPD/500mL/refg|Irradiated|ResLeu:<5log6
LPCW E5169 Washed RED BLOOD CELLS|None/XX/refg|Open|ResLeu:<5log6
LPCWI E5170 Washed RED BLOOD CELLS|None/XX/refg|Open|Irradiated|ResLeu:<5log6
LPED1 E0226 RED BLOOD CELLS|CPDA-1/500mL/refg|ResLeu:<5log6
LPED1I E0224 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated|ResLeu:<5log6
LPED2 E0226 RED BLOOD CELLS|CPDA-1/500mL/refg|ResLeu:<5log6
LPED2I E0224 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated|ResLeu:<5log6
Rev. June 2015 Product Codes • Page 26MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Leukoreduced RBCMBC Code
ISBT Product Code
Product Description
LPED3 E0226 RED BLOOD CELLS|CPDA-1/500mL/refg|ResLeu:<5log6
LPED3I E0224 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated|ResLeu:<5log6
LPED4 E0226 RED BLOOD CELLS|CPDA-1/500mL/refg|ResLeu:<5log6
LPED4I E0224 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated|ResLeu:<5log6
LPED5 E0226 RED BLOOD CELLS|CPDA-1/500mL/refg|ResLeu:<5log6
LPED5I E0224 RED BLOOD CELLS|CPDA-1/500mL/refg|Irradiated|ResLeu:<5log6
PUBS B0017 Washed RED BLOOD CELLS|None/500mL/refg|Open|Irradiated|ResLeu:<5log6|supernatant removed
E5362 E5362 RBC/CPD-500ml/refg/open/plasma reduced/res leu <5log6/irradiated/plasma added
E5363 E5363 RBC/CPD/500ml/refg/open/plasma reduced/res leu <5log6/plasma added
E5365 E5365 RBC/CPD/500ml/refg/open/plasma reduced/res leu <5log6
E5536*** E5536 RBC/CPDA-1/500ml/refg/open/plasma reduced/res leu <5log6/irradiated
E5627 E5627 RBC/CPDA-1/500ml/refg/open/plasma reduced/res leu <5log6
E5670 E5670 RBC/CPD-500ml/refg/open/plasma reduced/res leu <5log6/irradiated
E5677 E5677 RBC/CPDA-1/500ml/refg/open/plasma reduced/res leu <5log6/plasma added
E5678 E5678 RBC/CPDA-1/500ml/refg/open/plasma reduced/res leu <5log6/irradiated/plasma added
E5526 Reconstituted Whole Blood, from AS-3, 500 mL CP2D Whole Blood, Leukocytes Reduced
E5545 Red Blood Cells, AS-3, Supernatant Reduced
E5527 Reconstituted Whole Blood, from AS-3, 500 mL CP2D Whole Blood, Leukocytes Reduced, Irradiated
E5539 Red Blood Cells, AS-3, Supernatant Reduced, Irradiated
E0162 E0162 RED BLOOD CELLS|CPD/450mL/refg|Irradiated|ResLeu:<5log6
E0164 E0164 RED BLOOD CELLS|CPD/450mL/refg|ResLeu:<5log6
E0207 E0207 RED BLOOD CELLS|CPDA-1/450mL/refg|Irradiated|ResLeu:<5log6
E0209 E0209 RED BLOOD CELLS|CPDA-1/450mL/refg|ResLeu:<5log6
E0257 E0257 RED BLOOD CELLS|CP2D/450mL/refg|Irradiated|ResLeu:<5log6
E0259 E0259 RED BLOOD CELLS|CP2D/450mL/refg|ResLeu:<5log6
E0307 E0307 RED BLOOD CELLS|CPD>AS1/450mL/refg|Irradiated|ResLeu:<5log6
E0311 E0311 RED BLOOD CELLS|CPD>AS1/450mL/refg|ResLeu:<5log6
E0357 E0357 RED BLOOD CELLS|CP2D>AS3/450mL/refg|Irradiated|ResLeu:<5log6
E0361 E0361 RED BLOOD CELLS|CP2D>AS3/450mL/refg|ResLeu:<5log6
E0398 E0398 RED BLOOD CELLS|CPD>AS5/450mL/refg|Irradiated|ResLeu:<5log6
E0401 E0401 RED BLOOD CELLS|CPD>AS5/450mL/refg|ResLeu:<5log6
E0669 E0669 Apheresis RED BLOOD CELLS|CP2D>AS3/XX/refg|Irradiated|ResLeu:<5log6|2nd container
E0685 E0685 Apheresis RED BLOOD CELLS|CP2D>AS3/XX/refg|ResLeu:<5log6|1st container
E0686 E0686 Apheresis RED BLOOD CELLS|CP2D>AS3/XX/refg|ResLeu:<5log6|2nd container
E5122*** E5122 RED BLOOD CELLS|CPD>AS1/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag not adj
E5123 E5123 RED BLOOD CELLS|CPD>AS1/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag adj
E5124*** E5124 RED BLOOD CELLS|CP2D>AS3/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag not adj
E5125 E5125 RED BLOOD CELLS|CP2D>AS3/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag adj
E5126*** E5126 RED BLOOD CELLS|CPD>AS5/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag not adj
E5127 E5127 RED BLOOD CELLS|CPD>AS5/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag adj
E5155*** E5155 RED BLOOD CELLS|CPDA-1/XX/refg|ResLeu:<5log6|LowVol:anticoag not adj
E5156 E5156 RED BLOOD CELLS|CPDA-1/XX/refg|ResLeu:<5log6|LowVol:anticoag adj
E5157*** E5157 RED BLOOD CELLS|CPD>AS1/XX/refg|ResLeu:<5log6|LowVol:anticoag not adj
E5158 E5158 RED BLOOD CELLS|CPD>AS1/XX/refg|ResLeu:<5log6|LowVol:anticoag adj
E5240*** E5240 RED BLOOD CELLS|CPD/XX/refg|ResLeu:<5log6|LowVol:anticoag not adj
E5241 E5241 RED BLOOD CELLS|CPD/XX/refg|ResLeu:<5log6|LowVol:anticoag adj
E5242*** E5242 RED BLOOD CELLS|CP2D>AS3/XX/refg|ResLeu:<5log6|LowVol:anticoag not adj
E5243 E5243 RED BLOOD CELLS|CP2D>AS3/XX/refg|ResLeu:<5log6|LowVol:anticoag adj
E5244*** E5244 RED BLOOD CELLS|CPD>AS5/XX/refg|ResLeu:<5log6|LowVol:anticoag not adj
Rev. June 2015 Product Codes • Page 27MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Leukoreduced RBCMBC Code
ISBT Product Code
Product Description
E5245 E5245 RED BLOOD CELLS|CPD>AS5/XX/refg|ResLeu:<5log6|LowVol:anticoag adj
E5252*** E5252 RED BLOOD CELLS|CPD/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag not adj
E5253 E5253 RED BLOOD CELLS|CPD/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag adj
E5376*** E5376 RED BLOOD CELLS|CPDA-1/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag not adj
E5554 E5554 RED BLOOD CELLS|CP2D/XX/refg|ResLeu:<5log6|LowVol:anticoag adj
E5555 E5555 RED BLOOD CELLS|CPDA-1/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag adj
E5556 E5556 RED BLOOD CELLS|CP2D/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag adj
E5558*** E5558 RED BLOOD CELLS|CP2D/XX/refg|Irradiated|ResLeu:<5log6|LowVol:anticoag not adj
E5611*** E5611 RED BLOOD CELLS|CP2D/XX/refg|ResLeu:<5log6|LowVol:anticoag not adj
LPC5* E0424 RED BLOOD CELLS|CPD>AS5/500mL/refg|ResLeu:<5log6
LPC5I* E0420 RED BLOOD CELLS|CPD>AS5/500mL/refg|Irradiated|ResLeu:<5log6
SUR B0023 Single Unit Recovery|Aph RBCs|ACD-A>AS1|XX
Apheresis PlateletsMBC Code
ISBT Product Code
Product Description
LPH E3077 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6
E3078 Apheresis Platelets, Leukoreduced, Plasma Reduced (Single collection)
E3047 Apheresis Platelets, Leukoreduced, Plasma Reduced, Irradiated (Single collection)
E3080 Apheresis Platelets, Leukoreduced, Plasma Reduced, Bag 1
E3049 Apheresis Platelets, Leukoreduced, Plasma Reduced, Bag 1, Irradiated
E0381 Apheresis Platelets, Leukoreduced, Plasma Reduced, Bag 2
E3050 Apheresis Platelets, Leukoreduced, Plasma Reduced, Bag 2, Irradiated
LPH1 E3087 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|1st container
LPH1A E3087 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|1st container
LPH1AI E3056 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|1st container
LPH1B E3087 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|1st container
LPH1BI E3056 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|1st container
LPH1I E3056 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|1st container
LPH1V E3017 Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5log6|Plasma reduced|1st container
LPH1VI E2986 Apheresis PLATELETS|ACD-A/XX/20-24C|Open|Irradiated|ResLeu:<5log6|Plasma reduced|1st container
LPH1W E3558 Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5log6|1st container
LPH1WI E3543 Washed Apheresis PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5log6|1st container
LPH2 E3088 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|2nd container
LPH2A E3088 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|2nd container
LPH2AI E3057 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|2nd container
LPH2B E3088 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|2nd container
LPH2BI E3057 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|2nd container
LPH2I E3057 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|2nd container
LPH2V E3018 Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5log6|Plasma reduced|2nd container
LPH2VI E2987 Apheresis PLATELETS|ACD-A/XX/20-24C|Open|Irradiated|ResLeu:<5log6|Plasma reduced|2nd container
LPH2W E3559 Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5log6|2nd container
LPH2WI E3544 Washed Apheresis PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5log6|2nd container
LPH3 E3089 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|3rd container
LPH3A E3089 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|3rd container
LPH3AI E3058 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|3rd container
LPH3B E3089 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|3rd container
LPH3BI E3058 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|3rd container
Rev. June 2015 Product Codes • Page 28MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Apheresis PlateletsMBC Code
ISBT Product Code
Product Description
LPH3I E3058 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|3rd container
LPH3V E3019 Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5log6|Plasma reduced|3rd container
LPH3VI E2988 Apheresis PLATELETS|ACD-A/XX/20-24C|Open|Irradiated|ResLeu:<5log6|Plasma reduced|3rd container
LPH3W E3560 Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5log6|3rd container
LPH3WI E3545 Washed Apheresis PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5log6|3rd container
LPHA E3077 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6
LPHAI E3046 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6
LPHB E3077 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6
LPHBI E3046 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6
LPHC E4643 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|<3log11 plts
LPHC1 E4644 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|1st container|<3log11 plts
LPHC1I E4648 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|1st container|<3log11 plts
LPHC2 E4645 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|2nd container|<3log11 plts
LPHC2I E4649 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|2nd container|<3log11 plts
LPHC3 E4646 Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5log6|3rd container|<3log11 plts
LPHC3I E4650 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|3rd container|<3log11 plts
LPHCI E4647 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6|<3log11 plts
LPHI E3046 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5log6
LPHV E3015 Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5log6|Plasma reduced
LPHVI E2984 Apheresis PLATELETS|ACD-A/XX/20-24C|Open|Irradiated|ResLeu:<5log6|Plasma reduced
LPHW E3556 Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5log6
LPHWI E3541 Washed Apheresis PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5log6
PH1 * E3102 Apheresis PLATELETS|ACD-A/XX/20-24C|1st container
PH1I* E3071 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|1st container
PH2* E3103 Apheresis PLATELETS|ACD-A/XX/20-24C|2nd container
PH2I* E3072 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|2nd container
PHC* E4635 Apheresis PLATELETS|ACD-A/XX/20-24C|<3log11 plts
PHC1* E4636 Apheresis PLATELETS|ACD-A/XX/20-24C|1st container|<3log11 plts
PHC1I* E4640 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|1st container|<3log11 plts
PHC2* E4637 Apheresis PLATELETS|ACD-A/XX/20-24C|2nd container|<3log11 plts
PHC2I* E4641 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|2nd container|<3log11 plts
PHCI* E4639 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|<3log11 plts
PHI* E3045 Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated
PV E5346 PLATELETS|CPD/500mL/20-24C|Open|Plasma reduced
PVI E5347 PLATELETS|CPD/500mL/20-24C|Open|Irradiated|Plasma reduced
PW E2889 Washed PLATELETS|None/XX/20-24C|Open
PWI E2890 Washed PLATELETS|None/XX/20-24C|Open|Irradiated
E2807 E2807 PLATELETS|CPD/450mL/20-24C
E2809 E2809 PLATELETS|CPD/450mL/20-24C|Irradiated
E2833 E2833 PLATELETS|CPDA-1/450mL/20-24C
E2835 E2835 PLATELETS|CPDA-1/450mL/20-24C|Irradiated
E2851 E2851 PLATELETS|CP2D/450mL/20-24C
E2853 E2853 PLATELETS|CP2D/450mL/20-24C|Irradiated
E2854 E2854 PLATELETS|CP2D/450mL/20-24C|Irradiated|ResLeu:<8.3log5
E2857 E2857 Platelets|CP2D/450mL/20-24C|ResLeu:<8.3log5
Rev. June 2015 Product Codes • Page 29MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Platelet from Whole BloodMBC Code
ISBT Product Code
Product Description
PL E2824 PLATELETS|CPD/500ml/20-24C
PL2D* E2860 PLATELETS|CP2D/500mL/20-24C
PL2DI* E2862 PLATELETS|CP2D/500mL/20-24C|Irradiated
PLA1* E2842 PLATELETS|CPDA-1/500mL/20-24C
PLA1I* E2844 PLATELETS|CPDA-1/500mL/20-24C|Irradiated
PLI E2826 PLATELETS|CPD/500mL/20-24C|Irradiated
LPL E2866 Platelets|CP2D/500mL/20-24C|ResLeu:<8.3log5
LPLI E2863 PLATELETS|CP2D/500mL/20-24C|Irradiated|ResLeu:<8.3log5
LPLV E5613 PLATELETS|CP2D/500mL/20-24C|Open|ResLeu:<8.3log5|Plasma reduced
LPLVI E5614 PLATELETS|CP2D/500mL/20-24C|Open|Irradiated|ResLeu:<8.3log5|Plasma reduced
LPLW E2894 Washed PLATELETS|None/XX/20-24C|Open|ResLeu:<8.3log5
LPLWI E2891 Washed PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<8.3log5
Pooled PlateletsMBC Code
ISBT Product Code
Product Description
LPP E5710 POOLED PLATELETS|CP2D/XX/20-24C|ResLeu:<5log6|Bacterial monitoring
LPPI E5709 POOLED PLATELETS|CP2D/XX/20-24C|Irradiated|ResLeu:<5log6|Bacterial monitoring
LPPV E5650 POOLED PLATELETS|CP2D/XX/20-24C|Open|ResLeu:<5log6|Bacterial monitoring/Plasma reduced
LPPVI E5649 POOLED PLATELETS|CP2D/XX/20-24C|Open|Irradiated|ResLeu:<5log6|Bacterial monitoring/Plasma reduced
LPPVS B0021 POOLED PLATELETS|CP2D/XX/20-24C|Open|ResLeu:<5log6|Bacterial monitoring/Plasma reduced/Saline added
LPPVSI B0022 POOLED PLATELETS|CP2D/XX/20-24C|Open|Irradiated|ResLeu:<5log6|Bacterial monitoring/Plasma reduced/Saline added
LPPW E2921 Washed 'POOLED PLATELETS|None/XX/20-24C|Open|ResLeu:<5log6|Bacterial monitoring
LPPWI E2920 Washed POOLED PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5log6|Bacterial monitoring
E2983 Aph PLTS|ACD-A/Syringe Aliquot|Irrad|ResLeu:<5log6 (suffix indicated as A0, Ba, Bb, Bc, Bd, etc.)
E2993 Aph PLTS|ACD-A/Syringe Aliquot|Irrad|ResLeu:<5log6|1st cnt (suffix indicated as A0, Ba, Bb, Bc, Bd, etc.)
E2994 Aph PLTS|ACD-A/Syringe Aliquot|Irrad|ResLeu:<5log6|2nd cnt (suffix indicated as A0, Ba, Bb, Bc, Bd, etc.)
PP* E5151 POOLED PLATELETS|CPD/XX/20-24C|Open
PPI* E5226 POOLED PLATELETS|CPD/XX/20-24C|Open|Irradiated
PPV* E5348 POOLED PLATELETS|CPD/XX/20-24C|Open|Plasma reduced
PPVI* E5349 POOLED PLATELETS|CPD/XX/20-24C|Open|Irradiated|Plasma reduced
PPVS* B0002 POOLED PLATELETS|NS/XX/20-24C|Open|Plasma reduced|Saline added
PPVSI* B0003 POOLED PLATELETS|NS/XX/20-24C|Open|Irradiated|Plasma reduced|Saline added
PPW* E2918 Washed POOLED PLATELETS|None/XX/20-24C|Open
PPWI* E2919 Washed POOLED PLATELETS|None/XX/20-24C|Open|Irradiated
PlasmaMBC Code
ISBT Product Code
Product Description
AFP B0010 AUTOLOGOUS PLASMA (component is created and discarded)
CP* E3588 POOLED CRYOPRECIPITATE|None/XX/<=-18C|Open
CPP E2553 PLASMA|CPD/XX/<=-18C|Cryo reduced
CPP2D* E2617 PLASMA|CP2D/XX/<=-18C|Cryo reduced
CPPA1 E2585 PLASMA|CPDA-1/XX/<=-18C|Cryo reduced
CR E5165 CRYOPRECIPITATE|None/NS/<=-18C
E3587 Cryoprecipitated AHF, Pooled at Production
E3581 Thawed CRYOPRECIPITATE|None/NS/XX
Rev. June 2015 Product Codes • Page 30MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
PlasmaMBC Code
ISBT Product Code
Product Description
E3591 Cryprecipitated AHF, Pooled
E5304 Thawed Pooled plasma|CPD/XX/refg/Open|Cryp reduced
E5305 Thawed Pooled plasma|CP2D/XX/refg|Open|Cryo reduced
E2736 Thawed PLASMA|CP2D/XX/refg|Cryo reduced
E2720 Thawed PLASMA|CP2D/XX/refg
E2701 Thawed PLASMA |CPD/XX/refg|Frozen <=24h
E0773 Thawed PLASMA|CPD/XX/refg|Cryo reduced
FF E0701 FRESH FROZEN PLASMA|CPD/XX/<=-18C
FF1 E0707 FRESH FROZEN PLASMA|CPDA-1/XX/<=-18C
FF2 E0707 FRESH FROZEN PLASMA|CPDA-1/XX/<=-18C
FF2DI* E0716 FRESH FROZEN PLASMA|CP2D/XX/<=-18C|Irradiated
FF3 E0707 FRESH FROZEN PLASMA|CPDA-1/XX/<=-18C
FF4* E0707 FRESH FROZEN PLASMA|CPDA-1/XX/<=-18C
FFA1 E0707 FRESH FROZEN PLASMA|CPDA-1/XX/<=-18C
FFA1I* E0710 FRESH FROZEN PLASMA|CPDA-1/XX/<=-18C|Irradiated
FFI* E0704 FRESH FROZEN PLASMA|CPD/XX/<=-18C|Irradiated
FFPP E0869 Apheresis FRESH FROZEN PLASMA|ACD-A/XX/<=-18C
FFPP1 E0869 Apheresis Fresh FROZEN PLASMA|ACD-A/XX/<=-18C|Open|1st container
FFPP2 E0869 Apheresis Fresh FROZEN PLASMA|ACD-A/XX/<=-18C|Open|2nd container
FFPP3 E0869 Apheresis Fresh FROZEN PLASMA|ACD-A/XX/<=-18C|Open|3rd container
E0797 Thawed FRESH FROZEN PLASMA|CP2D/XX/refg
E1237 Thawed Apheresis FRESH FROZEN PLASMA|ACD-A/XX/refg
E0773 Thawed FRESH FROZEN PLASMA|CPD/XX/refg
E5275 Pooled Thawed Plasma, Frozen Within 24 Hours After Phlebotomy, from CPD Whole Blood
E5298 Pooled Thawed FFP from CPD Whole Blood
E5308 Pooled Thawed Plasma
E5309 Pooled Thawed Fresh Frozen Plasma
E6097 Pooled Thawed FFP, from ACD-A Apheresis
GR* E3676 Apheresis GRANULOCYTES|NaCitrate-HES/XX/rt|Open
GRI* E3677 Apheresis GRANULOCYTES|NaCitrate-HES/XX/rt|Open|Irradiated
DGAP* E2528 PLASMA|CPD/XX/<=-18C
DGAP2D* E2592 PLASMA|CP2D/XX/<=-18C
DGAPA1* E2560 PLASMA|CPDA-1/XX/<=-18C
FFPP4 E0869 Apheresis Fresh FROZEN PLASMA|ACD-A/XX/<=-18C|Open|4th container
FFPP5 E0869 Apheresis Fresh FROZEN PLASMA|ACD-A/XX/<=-18C|Open|5th container
FFPP6 E0869 Apheresis Fresh FROZEN PLASMA|ACD-A/XX/<=-18C|Open|6th container
E0900 E0900 Apheresis Fresh FROZEN PLASMA|ACD-A/XX/<=-18C|>=200mL <400mL
E4689 Apheresis Fresh FROZEN PLASMA|ACD-A
E4693 Apheresis Fresh FROZEN PLASMA|ACD-A
E4697 Apheresis Fresh FROZEN PLASMA|ACD-A
Memorial Blood Centers Testing
Memorial Blood CentersTesting CatalogDonor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
MBC.ORG/Products-and-Testing-Services/Products-and-Testing-Services-RelatedDocs
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 1 of 17 08/2015
Hepatitis B Virus
Hepatitis B Virus Surface Antigen (HBsAg) Test Code(s):
HBsAg - Neutralization performed on Repeat Reactive samples
HBsAg (No Reflex) – No further testing performed Manufacturer: BioRad Methodology: EIA Screening
Specimen Requirements: Specimen Volume: (excluding the red cell volume)
Storage Instructions:
Shipping Requirements:
Days Set Up: CPT Code:
Glass Tubes • Serum • Plasma (EDTA, sodium heparin, sodium citrate, CPDA-1 and ACD anticoagulants) Plastic Tubes • Serum, serum separator tubes • Plasma (EDTA, lithium heparin, and sodium citrate) Cadaveric - serum (glass or plastic) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.
1.5 ml
• 2-8ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the clot or red blood cells prior to freezing) • 5 Freeze/Thaw cycles
Ship at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to 7 days, and upon arrival should be stored at 2-8ºC. For transit times greater than 7 days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC).
Monday thru Saturday 87340
Hepatitis B Virus Surface Antigen Neutralization (HBsAg Confirmatory) Test Code:
HBsAg Neutralization Manufacturer: BioRad Methodology: EIA Confirmatory
Specimen Requirements: Specimen Volume: (excluding the red cell volume)
Storage Instructions:
Shipping Requirements: Days Set Up: CPT Code:
Glass Tubes • Serum • Plasma (EDTA, sodium heparin, sodium citrate, CPDA-1 and ACD anticoagulants) Plastic Tubes • Serum, serum separator tubes • Plasma (EDTA, lithium heparin, and sodium citrate) Cadaveric - serum (glass or plastic) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 1.0 ml • 2-8ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • 5 Freeze/Thaw cycles Ship at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to 7 days, and upon arrival should be stored at 2-8ºC. For transit times greater than 7 days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC). Monday/Tuesday, Wednesday, Friday 87341
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 2 of 17 08/2015
Hepatitis B Virus – continued
Antibody to Hepatitis B Virus Surface Antigen (Anti-HBs)
Sent to ViroMed for testing Test Code:
ADVIA Centaur Anti-HBs Manufacturer: ADVIA Centaur Methodology: Direct, chemiluminometric technology
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements:
Days Set Up: CPT Code:
• Serum • Plasma (EDTA or NA and LI heparin) • Do not use hemolyzed or heat-inactivated specimens NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 100 µl • Specimens should be removed from the cells within 2 hours from collection. • 8 hours at Room Temperature (15-28ºC) • 2-8ºC for 3 days • ≤ -20°C after 3 days (specimens should be removed from the red blood cells prior to freezing) • Avoid Multiple Freeze/Thaw cycles Specimens should be removed from the red blood cells and shipped frozen.
Monday thru Friday 86317
Antibody to Hepatitis B Core Antigen, Total (Anti-HBc Total) Test Code:
Anti-HBc Total Manufacturer: Ortho Clinical Diagnostics Methodology: EIA Screening
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum • Plasma (EDTA, heparin or citrate-based anticoagulants) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 0.5 ml • 2-8ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • 5 Freeze/Thaw cycles Specimens may be shipped at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to six days, and upon arrival should be stored at 2-8ºC. For transit times greater than six days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC). Monday thru Saturday 86704
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 3 of 17 08/2015
Hepatitis B Virus – continued
Antibody to Hepatitis B Core Antigen IgM (Anti-HBc IgM)
Sent to ViroMed for testing Test Code:
IMMULITE Anti-HBc IgM Manufacturer: IMMULITE 2000 Methodology: Immunochemiluminometric assay (ICMA)
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum • Plasma (EDTA) Do not use hemolyzed or heat-inactivated specimens NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 1.0 ml • 2 days at Room Temperature (15-28ºC) • 2-8ºC for 3 days • -20ºC after 3 days (specimens should be removed from the red blood cells prior to freezing) • 2 Freeze/Thaw cycles • Specimens which are not tested with in 24 hours should be removed from the cells Specimens should be removed from the cells prior to shipping. Specimens may be shipped at 2-8ºC for up to 3 days; and upon arrival should be frozen at ≤ -20°C. For transit times greater than 3 days, the specimen should be kept frozen at ≤ -20°C. Sunday thru Friday 86705
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 4 of 17 08/2015
Hepatitis C Virus
Antibody to Hepatitis C Virus (Anti-HCV) Test Code(s):
Anti-HCV - Repeat Reactive samples sent out for a PRISM HCV
Anti-HCV (No Reflex) - No further testing performed Manufacturer: Ortho Clinical Diagnostics Methodology: EIA Screening
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum, SST • Plasma (EDTA, lithium heparin, CPD, CP2D, CPDA-1, ACD or 4% citrate anticoagulants) • Cadaveric - Serum, SST or EDTA tubes NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 1.0 ml • 2-8ºC for 10 days • ≤ -20ºC after 10 days (no longer than 4 weeks; specimens should be removed from the red blood cells
prior to freezing) • 5 Freeze/Thaw cycles Specimens may be shipped at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to seven days, and upon arrival should be stored at 2-8ºC. For transit times greater than seven days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC) Monday thru Saturday 86803
Antibody to Hepatitis C Virus (Anti-HCV) Alternate Methodology
Sent to Indiana Blood Center for testing Test Code:
PRISM HCV Manufacturer: Abbott Laboratories Methodology: Abbott PRISM HCV (ChLIA)
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum, SST • Plasma (EDTA, potassium oxalate, sodium citrate, ACD-A, ACD-B, CP2D, CPD, or CPDA-1
anticoagulants or collected from segmented tubing) • Cadaveric – Serum NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 1.0 ml • 2-8ºC for 14 days • ≤ -20ºC after 14 days (specimens should be removed from the red blood cells prior to freezing) Specimens may be shipped at 30ºC or colder for a period not to exceed 7 days. If shipping the sample frozen, remove the serum or plasma from the clot or red blood cells prior to shipping. Monday thru Saturday 86803
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 5 of 17 08/2015
Human Immunodeficiency Virus (HIV)
Antibody to Human Immunodeficiency Viruses Type 1 and 2 plus O (Anti-HIV-1,2+O) Test Code(s):
Anti-HIV-1,2 plus O – Western Blot performed on Repeat Reactive samples
Anti-HIV-1,2 plus O (No Reflex) – No further testing performed Manufacturer: BioRad Methodology: EIA Screening
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum, SST • Plasma (EDTA, sodium & lithium heparin, sodium citrate, CPD, CPDA-1, and ACD) • Cadaveric - Serum NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 600ul • 2-8ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • 5 Freeze/Thaw cycles Specimens may be shipped refrigerated (2-8ºC) or at ambient temperature (≤37 ºC) for up to 7 days. For shipments that are in transit for more than 7 days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC). Monday thru Saturday 86703
Antibody to Human Immunodeficiency Virus Type 2 (Anti-HIV-2) Test Code(s):
Anti-HIV-2 – HIV-2 Immunoblot performed on Repeat Reactive samples
Anti-HIV-2 (No Reflex) – No further testing performed Manufacturer: BioRad Methodology: EIA Screening
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum • Plasma NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 200 µl • 2-8ºC for 7 days • ≤ -15ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • 5 Freeze/Thaw cycles Specimens may be shipped refrigerated (2-8ºC) for up to 7 days. For transit times greater than 7 days, the serum or plasma must be removed from the clot or red blood cells and kept frozen, (≤ -15ºC). Monday/Tuesday, Wednesday, Friday 86702
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 6 of 17 08/2015
Human Immunodeficiency Virus (HIV) – continued
Antibody to Human Immunodeficiency Virus Type 1 Western Blot (HIV-1 Western Blot) Test Code:
HIV-1 Western Blot Manufacturer: BioRad Methodology: BioRad – Western Blot
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum • Plasma (EDTA, heparin, sodium citrate, CPDA-1, and ACD) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 100 µl • 2-8ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • 5 Freeze/Thaw cycles Specimens may be shipped refrigerated (2-8ºC) or at ambient temperature (≤37 ºC) for up to 7 days. For shipments that are in transit for more than 7 days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC). Monday/Tuesday, Wednesday, Friday 86689
Antibody to Human Immunodeficiency Virus Type 2 Immunoblot (HIV-2 Immunoblot)
Sent to ViroMed for testing Test Code:
HIV-2 Immunoblot Manufacturer: Laboratory developed assay using analyte specific reagents
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum • EDTA Plasma NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing 100 µl • 2-8ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) Specimens may be shipped refrigerated (2-8ºC) for up to 7 days. For shipments that are in transit for more than 7 days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC). Tuesday, Thursday, Saturday 86689
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 7 of 17 08/2015
Human T-Lymphotropic Virus (HTLV)
Antibody to Human T-Lymphotropic Virus Type I and II (Anti-HTLV I/II) Test Code(s):
Avioq HTLV-I/II - Repeat Reactive samples sent out for a PRISM HTLV-I/II
Avioq HTLV-I/II (No Reflex) – No further testing performed
Manufacturer: Avioq
Methodology: EIA Screening
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions:
Shipping Requirements: Days Set Up: CPT Code(s):
• Serum, SST • Plasma (EDTA, heparin, citrate, CPD, CPDA-1 anticoagulants or collected from segmented tubing) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 0.5 ml • 2-8ºC for 14 days • ≤ -20ºC after 14 days (specimens should be removed from the red blood cells prior to freezing) • 1 Freeze/Thaw cycle
Specimens may be shipped at ambient temperature, refrigerated (2-8ºC) or frozen (≤ -20ºC). Prior to freezing, serum or plasma must be removed from the clot or red blood cells. Monday thru Saturday 86687 / 86688
Antibody to Human T-Lymphotropic Virus Type I and II (Anti-HTLV I/II) Alternate Methodology
Sent to Indiana Blood Center for testing Test Code:
PRISM HTLV-I/II Manufacturer: Abbott Laboratories Methodology: Abbott PRISM HTLV-I/II (ChLIA)
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code(s):
• Serum, SST • Plasma (EDTA, potassium oxalate, sodium citrate, ACD-A, ACD-B, CP2D, CPD, or CPDA-1
anticoagulants or collected from segmented tubing) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 1.0 ml • 2-8ºC for 14 days • ≤ -20ºC after 14 days (specimens should be removed from the red blood cells prior to freezing) Specimens may be shipped at 30ºC or colder for a period not to exceed 7 days if removed from clot or cells. Prior to freezing, serum or plasma must be removed from the clot or red blood cells. Monday thru Saturday 86687 / 86688
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 8 of 17 08/2015
Human T-Lymphotropic Virus (HTLV) – continued
Antibody to Human T-Lymphotropic Virus Type I and II Immunoblot (HTLV I/II Immunoblot)
Sent to ViroMed for testing Test Code:
HTLV-I/II Immunoblot
Manufacturer: Innogenetics Methodology: Line Blot
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum, SST • Plasma (EDTA, heparin, citrate anticoagulants) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 0.5 ml • 2-8ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the red blood cells prior to freezing) • 3 Freeze/Thaw cycle Specimens may be shipped refrigerated (2-8ºC) for up to 7 days, or frozen (≤ -20ºC). Prior to freezing, serum or plasma must be removed from the clot or red blood cells. Tuesday, Thursday 86689 RUO - Research use only, not for diagnostic purposes
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 9 of 17 08/2015
Trypanosoma cruzi (T.cruzi)
Antibody to Trypanosoma cruzi (Anti-T.cruzi) Test Code(s):
Anti-T.cruzi - Repeat Reactive samples sent out for a PRISM Chagas
Anti-T.cruzi (No Reflex) - No further testing performed Manufacturer: Ortho Clinical Diagnostics Methodology: EIA Screening
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum, SST • Plasma (EDTA, lithium heparin, CPD, CP2D, CPDA-1, ACD or 4% citrate anticoagulants) • Cadaveric – Serum, SST or EDTA NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 1.0 ml • Up to 37ºC for 24 hours • 2-8ºC for 10 days • ≤ -20ºC after 10 days up to 4 weeks (Can be stored for 6 months with 1 freeze/thaw cycle) • 5 Freeze/Thaw cycles Specimens may be shipped at ambient temperature (up to 37ºC) or refrigerated (2-8ºC) for up to 7 days, and upon arrival should be stored at 2-8ºC. For transit times greater than seven days, the serum or plasma must be removed from the clot or red blood cells and should be kept frozen, (≤ -20ºC). Monday thru Saturday 86753
Antibody to Trypanosoma cruzi (Anti-T.cruzi) Alternate Methodology
Sent to Indiana Blood Center for testing Test Code:
PRISM Chagas Manufacturer: Abbott Laboratories Methodology: Abbott PRISM Chagas (ChLIA)
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum, SST • Plasma (EDTA, potassium oxalate, sodium citrate, ACD-A, ACD-B, CP2D, CPD, or CPDA-1
anticoagulants or collected from segmented tubing) • Cadaveric – Serum only NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.
1.0 ml • 30ºC or colder for up to7 days • 2-8ºC or -20ºC or colder for up to, but may not exceed, 14 days (specimens should be removed from the
red blood cells prior to freezing) Specimens may be shipped at 30ºC or colder for up to 7 days, or 2-8°C or -20°C or colder for up to 14 days. Prior to freezing, serum or plasma must be removed from the clot or red blood cells. Monday thru Saturday
86753
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 10 of 17 08/2015
Serologic Test for Syphilis (STS)
NEO Treponema Pallidum System for detection of Syphilis (Syphilis TPHA)
Test Code(s): Syphilis TPHA – Syphilis MHA-TP performed on repeat reactive samples
Syphilis TPHA (No Reflex) - No further testing performed Manufacturer: Immucor
Methodology: Hemagglutination
**Primary method for Non-Blood Donors**
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum • Plasma (EDTA) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 2.0 ml • 1-10ºC for 7 days • ≤ -20ºC after 7 days (specimens should be removed from the clot or red blood cells prior to
freezing) • 3 Freeze/Thaw cycles
Specimens may be shipped refrigerated (1-10ºC) for up to 7 days, or frozen (≤ -20ºC). Prior to freezing, serum or plasma must be removed from the clot or red blood cells. Monday thru Saturday 86780 – STS – Treponema Pallidum
PK Treponema Pallidum System for detection of Syphilis (Syphilis MHA-TP) Test Code: Syphilis MHA-TP
Note: On Blood Donor samples (and when this assay is used as a backup for the NEO), a Syphilis TPHA is performed on repeat reactive samples Manufacturer: Beckman Coulter Methodology: Microhemagglutination
**Primary method for Blood Donors**
Specimen Requirements:
Specimen Volume: (excluding the red cell volume)
Storage Instructions:
Shipping Requirements:
Days Set Up: CPT Code:
• Plasma (EDTA) • Serum NOTE: Specimens collected with an improper ratio of specimen to anticoagulant cannot be used for testing.
2.0 ml
• 2-8ºC - up to 5 days • ≤ -20ºC after 5 days (specimens should be removed from the clot or red blood cells prior to freezing) • Avoid repeat Freeze/Thaw cycles
Serum should be removed from the clot or red blood cells within 5 days from collection and ship frozen.
Monday thru Saturday
86780 – STS – Treponema Pallidum 86780 – FTA-ABS
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 11 of 17 08/2015
Serologic Test for Syphilis (STS) – continued
Fluorescent Treponemal Antibody Absorption Test (FTA-ABS)
Sent to ViroMed for testing Test Code: Syphilis FTA-ABS Manufacturer: MarDX Methodology: Indirect Fluorescent Antibody (IFA)
Specimen Requirements: Specimen Volume: Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum 1.0 ml • 2-8ºC - up to 5 days • ≤ -20ºC after 5 days (specimens should be removed from the clot or red blood cells prior to freezing) • 3 Freeze/Thaw cycles Specimen should be removed from the clot within 5 days from collection and ship frozen. Monday thru Friday 86780 – FTA-ABS
Rapid Plasma Reagin (RPR)
Sent to ViroMed for testing Test Code: Syphilis RPR Manufacturer: BD Macro-Vue Methodology: Charcoal Flocculation
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum 0.5 ml
• 2-8ºC - up to 5 days • ≤ -20ºC after 5 days (specimens should be removed from the clot or red blood cells prior to freezing) • 3 Freeze/Thaw cycles Serum should be removed from the clot or red blood cells within 5 days from collection and ship frozen. Daily 86592 – RPR
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 12 of 17 08/2015
Nucleic Acid Testing (NAT)
COBAS TaqScreen MPX Test (HIV/HCV/HBV PCR) Test Code(s): MPX – sent out for discriminatory testing by HIV-PCR, HCV-PCR, and HBV-PCR if reactive. MPX (No Reflex) – no discriminatory testing performed
This test is for the eligibility determination of Donors of blood and blood components and human cells, tissues and cellular tissue based products (HCT/Ps). This test is not intended to be used for routine clinical or diagnostic evaluation.
Manufacturer: Roche
Methodology: Roche RNA Polymerase Chain Reaction
Specimen Requirements:
Specimen Volume:
Storage Instructions:
Shipping Requirements: Days Set Up: CPT Code(s):
• Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and 4% Sodium Citrate) *EDTA is the recommended specimen, the other anticoagulants have more stringent storage requirements that are difficult to comply with when shipping specimens for testing. Please call the lab for the requirement if needed. NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.
1 full 7 ml EDTA plasma tube
EDTA only Specimens should be removed from the red blood cells prior to freezing. • 2-30ºC for 72 hours • 2-8ºC for 5 days • 2-8ºC for days 6-12 if separated from cells • ≤ -18ºC for days 12-30 • 3 Freeze/Thaw cycles
EDTA plasma samples should be shipped within the storage specifications. Monday thru Saturday HIV PCR – 87535 HCV PCR – 87521 HBV PCR – 87516
COBAS AmpliScreen HIV-1, HCV, HBV Individual Tests (HIV-PCR/HCV-PCR/HBV-PCR)
Sent to Indiana Blood Center for testing Test Code(s): HIV PCR HCV PCR HBV PCR This test is performed individually. It is used as the discriminatory testing if the MPX test is reactive. This test is not intended to be used for routine clinical or diagnostic evaluation.
Manufacturer: Roche
Methodology: Roche RNA Polymerase Chain Reaction
Specimen Requirements:
Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code(s):
• Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and 4% Sodium Citrate) *EDTA is the recommended specimen, the other anticoagulants have more stringent storage requirements that are difficult to comply with when shipping specimens for testing. Please call the lab for the requirement if needed. NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing.
1.0 ml for 1 test or 2.0 ml’s for 2-3 tests EDTA only Specimens should be removed from the red blood cells prior to freezing. • 2-30ºC for 72 hours • 2-8ºC for 5 days • 2-8ºC for days 6-12 if separated from cells • ≤ -18ºC for days 12-30 • 3 Freeze/Thaw cycles EDTA plasma samples should be shipped within the storage specifications. Monday thru Saturday HIV PCR – 87535 HCV PCR – 87521
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 13 of 17 08/2015
HBV PCR – 87516
Nucleic Acid Testing (NAT) - continued
COBAS Taqscreen WNV Test (WNV PCR) Test Code: WNV PCR This test is for the eligibility determination of Donors of blood and blood components. This test is not intended to be used for routine clinical or diagnostic evaluation. Manufacturer: Roche Methodology: Roche RNA Polymerase Chain Reaction
Specimen Requirements: Specimen Volume: Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and 4% Sodium Citrate). *EDTA is the recommended specimen, the other anticoagulants have more stringent storage requirements that are difficult to comply with when shipping specimens for testing. Please call the lab for the requirement if needed. NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 1 full 7 ml EDTA plasma tube EDTA only Specimens should be removed from the red blood cells prior to freezing. • 2-30ºC for 24 hours followed by 24 hours at 2-25 ºC OR 2 days at 2-25 ºC • 2-8ºC to 5 days • 2-8ºC for days 6-12 if separated from cells • ≤ -20ºC for days 12-30 • 3 Freeze/Thaw cycles EDTA plasma samples should be shipped within the storage specifications. Monday thru Saturday 87798
MBC Testing Catalog Donor Testing Laboratory
Viral Screening, Red Cell Typing, Nucleic Acid Testing
CONFIDENTIAL/PROPRIETARY: Distribution outside company with permission only. IBR-JOB-AID-Org DT Job Aid-0030.02 Innovative Blood Resources, St. Paul, MN / Memorial Blood Centers / Nebraska Community Blood Bank Page 14 of 17 08/2015
Cytomegalovirus (CMV)
Antibody to Cytomegalovirus (Anti-CMV Total(IgG+IgM Antibody)) Test Code(s):
Capture-CMV Total (IgG / IgM Reflex) – CMV IgG and CMV IgM are performed on reactive samples
Capture-CMV Total (IgM Reflex) – CMV IgM is performed on reactive samples
Capture-CMV Total (No Reflex) – No further testing is performed
Manufacturer: Immucor
Methodology: Immucor Capture-CMV – solid phase – automated
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum – Samples collected in a tube containing a neutral gel separator are NOT acceptable.( False positive results may occur.)
• Plasma (EDTA, ACD, CPD, CPDA-1 or CP2D) NOTE: Specimens collected with an improper ratio of specimen to anticoagulant can not be used for testing. 1.0 ml • 1-10ºC for 7 days (Serum, EDTA, ACD, CPD) • 1-10ºC for 42 days as whole blood (CPDA-1, CP2D) • ≤ -20ºC after 7 days (specimens should be removed from the clot or red blood cells prior to freezing) • Avoid repeat Freeze/Thaw cycles Samples should be shipped within the storage specifications. Monday thru Saturday 86644
Cytomegalovirus IgM Antibody (Anti-CMV IgM) Test Code:
CMV IgM EIA
Manufacturer: BioRad
Methodology: EIA
Specimen Requirements: Specimen Volume: (excluding the red cell volume) Storage Instructions: Shipping Requirements: Days Set Up: CPT Code:
• Serum 0.5 ml The serum should be removed from the clot. • 2-8ºC for 48 hours • ≤ -20ºC after 48 hours • Avoid multiple Freeze/Thaw cycles Samples should be shipped within the storage specifications. Monday, Wednesday, Friday 86645
Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 31MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Memorial Blood Centers Testing
Donor Testing LaboratoryViral Screening, Red Cell Typing, Nucleic Acid Testing
Hepatitis B Virus
Hepatitis B Virus Surface Antigen (HBsAg)
Test Code:HBsAg(Neutralization performed on Reactive samples for confirmation)
Methodology: BioRad – EIA Screening
Specimen Requirements: • Serum• Plasma (EDTA, sodium & lithium heparin, sodium citrate, CPDA-1
and ACD anticoagulants)• Cadaveric serum specimen
Specimen Volume: 3 ml
Storage Instructions: • 2–8º C for 7 days• ≤ -20º C after 7 days• 5 Freeze/Thaw cycles
Shipping Requirements: Ship at ambient temperature (up to 37º C) or refrigerated (2–8º C) for up to 7 days, and upon arrival should be stored at 2–8º C. For transit times greater than 7 days, the specimens should be kept frozen (≤ -20º C).
Days Set Up: Monday through Saturday
CPT Code: 87340
Hepatitis B Virus Surface Antigen Neutralization (HBsAg Neutralization)
Test Code: HBsAg Neutralization
Methodology: BioRad – EIA
Specimen Requirements: • Serum• Plasma (EDTA, sodium & lithium heparin, sodium citrate, CPDA-1
and ACD anticoagulants)• Cadaveric serum specimen
Specimen Volume: 2 ml
Storage Instructions: • 2–8º C for 7 days• ≤ -20º C after 7 days• 5 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37º C) or refrigerated (2–8º C) for up to 7 days, and upon arrival should be stored at 2–8º C. For transit times greater than 7 days, the specimens should be kept frozen (≤ -20º C).
Days Set Up: Tuesday, Thursday and Friday
CPT Code: 87341
Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 32MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Hepatitis B Virus continued
Antibody to Hepatitis B Virus Surface Antigen Quantitation (Anti-HBs)
Sent to ViroMed for Testing
Test Code: Anti-HBs
Methodology: Immulite 2000 — Chemiluminescent EIA
Specimen Requirements: • Serum• Plasma (EDTA or heparin)• Do not use hemolyzed or heat-inactivated specimens
Specimen Volume: 100 μl
Storage Instructions: • Room Temp for 2 days• 2–8º C for 3 days• ≤ -20° C after 3 days• Multiple Freeze/Thaw cycles not recommended
Shipping Requirements: Shipping conditions not specified
Days Set Up: Monday through Friday
CPT Code: 86317
Antibody to Hepatitis B Core Antigen, Total (Anti-HBc Total)
Test Code: Anti-HBc Total
Methodology: Ortho Clinical Diagnostics — EIA ScreeningDetects IgG and IgM antibodies.
No additional testing required for confirmation of a Reactive sample.
Specimen Requirements: • Serum• Plasma (EDTA, heparin or citrate-based anticoagulants)
Specimen Volume: 600 μl
Storage Instructions: • 2–8º C for 7 days• ≤ -20º C after 7 days• 5 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37º C) or refrigerated (2–8º C) for up to six days, and upon arrival should be stored at 2–8º C. For transit times greater than six days, the specimens should be kept frozen (≤ -20º C).
Days Set Up: Monday through Saturday
CPT Code: 86704
Hepatitis B Virus e (envelope) Antigen (HBeAg)
Test Code: HBeAg
Methodology: Diasorin — EIA
Specimen Requirements: Serum — non hemolyzed
Specimen Volume: 1 ml
Storage Instructions: • 2–8º C for 48 hours• ≤ -20º C after 48 hours• 1 Freeze/Thaw cycle
Shipping Requirements: Samples should be shipped on wet or dry ice depending on previously stated storage requirements.
Days Set Up: Monday
CPT Code: 87350
Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 33MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Hepatitis B Virus continued
Antibody to Hepatitis B virus e Antigen (Anti-HBe)
Test Code: Anti-HBe
Methodology: Diasorin — EIA
Specimen Requirements: Serum — non hemolyzed
Specimen Volume: 600 μl
Storage Instructions: • 2–8º C for 48 hours• ≤ -20º C after 48 hours• 1 Freeze/Thaw cycle
Shipping Requirements: Samples should be shipped on wet or dry ice depending on previously stated storage requirements.
Days Set Up: Monday
CPT Code: 86707
Hepatitis C Virus
Antibody to Hepatitis C Virus (Anti-HCV)
Test Code: Anti-HCV (RIBA performed on Reactive samples for confirmation) or Anti-HCV — No Reflex (No RIBA is performed if sample is Reactive)
Methodology: Ortho Clinical Diagnostics — EIA Screening
Specimen Requirements: • Serum• Plasma (EDTA, heparin or citrate-based anticoagulants)
Specimen Volume: 700 μl — Anti-HCV600 μl — Anti-HCV — No Reflex
Storage Instructions: • 2–8º C for 7 days• ≤ -20º C after 7 days• 5 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37º C) or refrigerated (2–8º C) for up to six days, and upon arrival should be stored at 2–8º C. For transit times greater than six days, the specimens should be kept frozen (≤ -20º C).
Days Set Up: Monday through Saturday
CPT Code: 86803 — Anti-HCV86803 — Anti-HCV — No Reflex
Recombinant Immunoblot Assay (RIBA) for Antibody to Hepatitis C Virus (RIBA)
Test Code: RIBA
Methodology: Chiron — SIA — v. 3.0
Specimen Requirements: • Serum• Plasma (K3EDTA, sodium heparin, ACD, CPDA-1, or 4% sodium
citrate)
Specimen Volume: 500 μl
Storage Instructions: • 2–8º C for 7 days• ≤ -20º C after 7 days• Avoid multiple Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped at ambient temperature (up to 37º C) or refrigerated (2–8º C) for up to seven days, and upon arrival should be stored at 2–8º C. For transit times greater than seven days, the specimens should be kept frozen (≤ -20º C).
Days Set Up: Tuesday, Thursday
CPT Code: 86804
Human Immunodeficiency Virus (HIV)
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Human Immunodeficiency Virus (HIV) continued
BioRad Antibody to Human Immunodeficiency Virus Type 1 rLAV EIA (Anti-HIV-1)
Test Code: Anti-HIV-1 (Western Blot performed on Reactive samples for confirmation)
Methodology: BioRad — EIA — viral lysate and E. coli recombinant antigen
Specimen Requirements: • Serum• Plasma (EDTA, heparin, sodium citrate, CPDA-1, and ACD)
Specimen Volume: 600 μl
Storage Instructions: • 2–8º C for 7 days• ≤ -20º C after 7 days• 5 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped refrigerated (2–8º C) or at ambient temperature for up to 7 days. For shipments that are in transit for more than 7 days, specimens should be kept frozen (≤ -20º C).
Days Set Up: Wednesday
CPT Code: 86701
Antibody to Human Immunodeficiency Viruses Type 1 and 2 plus O (Anti-HIV-1/2 + O)
Test Code: Anti-HIV-1,2 (Western Blot performed on Reactive samples for confirmation)
Methodology: BioRad — EIA screening
Specimen Requirements: • Serum (Cadaveric serum is also acceptable)• Plasma (EDTA, sodium & lithium heparin, sodium citrate, CPD,
CPDA-1, and ACD)
Specimen Volume: 1 ml
Storage Instructions: • 2–8º C for 7 days• ≤ -20º C after 7 days• 5 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped refrigerated (2–8º C) or at ambient temperature for up to 7 days. For shipments that are in transit for more than 7 days, specimens should be kept frozen (≤ -20º C).
Days Set Up: Monday through Saturday
CPT Code: 86703
Antibody to Human Immunodeficiency Virus Type 2 (Anti-HIV-2)
Test Code: Anti-HIV-2 or Anti-HIV-2 — Reflex (Sent to ViroMed for an HIV-2 Immunoblot if sample is Reactive)
Methodology: BioRad — EIA
Specimen Requirements: • Serum• Plasma
Specimen Volume: 600 μl
Storage Instructions: • 2–8º C for 7 days• ≤ -20º C after 7 days• Freeze/Thaw cycles not specified
Shipping Requirements: Shipping conditions not specified
Days Set Up: Wednesday
CPT Code: 86702 — Anti-HIV-286689 — HIV-2 Immunoblot
Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 35MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Human Immunodeficiency Virus (HIV) continued
Antibody to Human Immunodeficiency Virus Type 1 Western Blot (HIV-1 Western Blot)
Test Code: HIV-1 Western Blot
Methodology: BioRad — Western Blot
Note: Sent to Mayo Clinic for HIV-1 IFA testing if the blot is unreadable on 2 runs.
Specimen Requirements: • Serum• Plasma
Specimen Volume: 500 μl
Storage Instructions: • 2–8º C for 7 days• ≤ -20º C after 7 days• 5 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped refrigerated (2–8º C) or at ambient temperature for up to 7 days. For shipments that are in transit for more than 7 days, specimens should be kept frozen (≤ -20º C).
Days Set Up: Wednesday and Friday
CPT Code: 86689 — HIV-1 WB86689 — HIV-1 IFA
Antibody to Human Immunodeficiency Virus Type 1 Immuno Fluorscence Assay (HIV-1 IFA) — See HIV-1 Western Blot
Antibody to Human Immunodeficiency Virus Type 2 Immunoblot (Anti-HIV-2 Immunoblot) — See Anti-HIV-2
Human T-Lymphotropic Virus (HTLV)
Antibody to Human T-Lymphotropic Virus Type I and II (Anti-HTLV I/II)
Test Code: Anti-HTLV I/II or Anti-HTLV I/II — EIA Reflex (Sent to LifeSource for confirmation testing by Abbott EIA if sample is Reactive.) or Anti-HTLV I/II — Donor Reflex (Sent to ViroMed for HTLV Immunoblot if sample is Reactive.)
Methodology: Abbott Prism chemiluminescent assay (CHLIA)
Specimen Requirements: • Serum• Plasma (EDTA, potassium oxalate, ACD, heparin, citrate,
CPD or CPDA-1 anticoagulants)
Specimen Volume: 500 μl
Storage Instructions: • 2–8º C for 14 days• ≤ -20º C after 14 days• 6 Freeze/Thaw cycle
Shipping Requirements: Specimens may be shipped ambient, refrigerated (2–8º C), or frozen (≤ -20º C).
Days Set Up: Monday through Saturday
CPT Code: 86687/86688 — HTLV EIA Screen86687/86688 — Alternate EIA Method Confirmation86689 — HTLV I/II Immunoblot
Antibody to Human T-Lymphotropic Virus Type I and II Immunoblot (Anti-HTLV-I/II Immunoblot) — See Anti-HTLV I/II
Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 36MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Trypanosoma cruzi (T.cruzi)
Antibody to Trypanosoma cruzi (Anti-T.cruzi)
Test Code: Anti-T.cruzi
Sent to Quest for RIPA if sample is Reactive
Methodology: Ortho — EIA Screening
Specimen Requirements: • Serum• Plasma (EDTA, lithium heparin, CPD, CP2D, CPDA-1, ACD or 4%
citrate anticoagulants)
Specimen Volume: 600 μl
Storage Instructions: • 2–8º C for 10 days• ≤ -20º C after 10 days• 5 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped ambient, refrigerated (2–8º C), or frozen (≤ -20º C).
Days Set Up: Monday through Saturday
CPT Code: 86753 — T.cruzi EIA Screen86753 — RIPA Confirmation
T.cruzi Radioimmunoprecipitation Assay (RIPA)
Se nt to Quest Diagnostics for testing Set up Monday & Thursday morning Results in 12+ days
Methodology: Radioimmunoprecipitation
Specimen Requirements: • Serum — Preferred• Plasma (EDTA) — Acceptable
Specimen Volume: 1 mL (minimum 500 μl)
Storage Instructions: • 2–8º C for 10 days• ≤ -20º C after 10 days (up to 6 months)• Freeze/Thaw cycles not specified
Shipping Requirements: Aliquot in a clean screw top vial. Specimens may be shipped refrigerated (2–8º C) or frozen (≤ -20º C).
CPT Code: 86753 — RIPA Confirmation
Serologic Test for Syphilis (STS)
Macro-Vue RPR Card Test for detection of Syphilis (Syphilis RPR)
Test Code: Syphilis RPR
Sent to ViroMed for confirmation by FTA-ABS if Reactive
Methodology: Latex Agglutination
Specimen Requirements: • Serum• Plasma (EDTA, heparin, potassium oxalate, potassium sequestrene
or sodium fluoride (if testing samples <24 hours old)
Specimen Volume: 1.5 ml
Storage Instructions: • 2–8º C in original collecting tube• ≤ -20º C• Freeze/Thaw cycles not specified
Shipping Requirements: Shipping conditions not specified
Days Set Up: Monday through Saturday
CPT Code: 86592 — STS86781 — FTA-ABS
Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 37MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Serologic Test for Syphilis (STS)
Olympus PK Treponema Pallidum System for detection of Syphilis (Syphilis TP)
Test Code: Syphilis TP
Sent to ViroMed for confirmation by FTA-ABS if Reactive
Methodology: Microhemagglutination
Specimen Requirements: • Plasma (EDTA)• Serum
Specimen Volume: 1.5 ml
Storage Instructions: • 2–8º C — up to 5 days• ≤ -20º C after 5 days• Avoid repeat Freeze/Thaw cycles
Shipping Requirements: Shipping conditions not specified.
Days Set Up: Monday through Saturday
CPT Code: 86592 — STS86781 — FTA-ABS
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Nucleic Acid Testing (NAT)
COBAS AmpliScreen HIV-1 and HCV Test (HIV/HCV PCR)
This test is for the eligibility determination of donors of blood and blood components and human cells, tissues and cellular tissue based products (HCT/Ps).
This test is not intended to be used for routine clinical or diagnostic evaluation.
Test Code: HIV/HCV PCR
Methodology: Roche RNA Polymerase Chain Reaction
Specimen Requirements: Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and 4% sodium citrate).
* EDTA is the recommended specimen, the other anticoagulants have more stringent storage requirements that are difficult to comply with when shipping specimens for testing.
Specimen Volume: 1 full 7 ml EDTA plasma tube
Storage Instructions: EDTA only• 2–8º C for 5 days• 2–8º C for days 6–12 if separated from cells• ≤ -18º C for days 15–30• 3 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped refrigerated (2-8ºC) or at ambient temperature for up to 3 days. Specimens over 5 days old cannot be tested unless they were centrifuged at 800–1600 × g for 20 minutes and removed from the cells. False positive results can occur from cross contamination if samples are not handled under a hood.
Days Set Up: Monday through Saturday
CPT Code: HIV PCR — 87535HCV PCR — 87521
COBAS AmpliScreen HBV Test (HBV PCR)
This test is for the eligibility determination of donors of blood and blood components and human cells, tissues and cellular tissue based products (HCT/Ps).
This test is not intended to be used for routine clinical or diagnostic evaluation.
Test Code: HBV PCR
Methodology: Roche DNA Polymerase Chain Reaction
Specimen Requirements: Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and 4% Sodium Citrate).
* EDTA is the recommended specimen, the other anticoagulants have more stringent storage requirements that are difficult to comply with when shipping specimens for testing.
Specimen Volume: 1 full 7 ml EDTA plasma tube
Storage Instructions: EDTA only• 2–8º C for 5 days• 2–8º C for days 6–12 if separated from cells• ≤ -18º C for days 15–30• 3 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped refrigerated (2–8º C) or at ambient temperature for up to 3 days. Specimens over 5 days old cannot be tested unless they were centrifuged at 800–1600 × g for 20 minutes and removed from the cells. False positive results can occur from cross contamination if samples are not handled under a hood.
Days Set Up: Monday through Saturday
CPT Code: 87516
Rev. June 2015 Memorial Blood Centers Testing Catalog • Page 39MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Nucleic Acid Testing (NAT) continued
COBAS Taqscreen WNV Test (WNV PCR)
This test is for the eligibility determination of donors of blood and blood components.
This test is not intended to be used for routine clinical or diagnostic evaluation.
Test Code: WNV PCR
Methodology: Roche RNA Polymerase Chain Reaction
Specimen Requirements: Plasma (EDTA*, CPD, CPDA-1, CP2D, ACD-A and 4% Sodium Citrate).
* EDTA is the recommended specimen, the other anticoagulants have more stringent storage requirements that are difficult to comply with when shipping specimens for testing.
Specimen Volume: 1 full 7 ml EDTA plasma tube
Storage Instructions: EDTA only• 2–8º C for 5 days• 2–8º C for days 6–12 if separated from cells• ≤ -18º C for days 15–30• 3 Freeze/Thaw cycles
Shipping Requirements: Specimens may be shipped refrigerated (2–8º C) or at ambient temperature for up to 3 days. Specimens over 5 days old can not be tested unless they were centrifuged at 800–1600 × g for 20 minutes and removed from the cells. False positive results can occur from cross contamination if samples are not handled under a hood.
Days Set Up: Monday through Saturday
CPT Code: 87798
Rev. June 2015 Quality Assurance • Page 41MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Quality Assurance
Physician Services and Quality and Regulatory Affairs
Memorial Blood Centers’ Physicians and Quality and Regulatory Affairs staff are available to answer any questions related to quality, regulations or transfusion medicine in general. Our highly trained staff includes physicians, specialists in blood banking, and medical technologists. Several of Memorial Blood Centers staff serve on committees, as board members or as assessors for professional organizations such as AABB, America’s Blood Centers (ABC), Foundation for the Accreditation of Cellular Therapy (FACT), and National Marrow Donor Program (NMDP). A physician is available for consultation at all times and may be contacted through Hospital Services during non-business hours.
Information on Memorial Blood Centers’ licensing and accreditations are available at MBC.ORG/About-Us/Accreditations.
Quarantine, Market Withdrawal, Recall, Inventory Lookback and Recipient NotificationOccasionally Memorial Blood Centers will request that you quarantine an in-date blood component if it is still in your inventory. You will be notified by phone and by fax of any in-date components that need to be quarantined. If the component has already been transfused, you will receive a letter if recipient notification or tracing is necessary.
It may be necessary for Memorial Blood Centers to request the return of a unit of blood and/or blood component that was issued to your facility. When the safety, quality, purity, potency or identity of a component may be affected, a market withdrawal or recall letter will be sent directly to the physician in charge of your Transfusion Service, indicating the reason for the market withdrawal or recall.
If you are notified of a market withdrawal or recall, it is imperative that you:1. Immediately quarantine any in-date components
in inventory at your facility.2. Complete necessary documentation and return to
Memorial Blood Centers as requested so we can:• Verify that your facility received notification;• Verify that your facility received the component
involved;• Complete final disposition records as required
by FDA.
Reporting Adverse Outcomes of Transfusion
Transfusion Services are required to have a mechanism in place to document and track adverse events related or potentially related to transfusion. The Serious Outcome of Transfusion (SOOT) Report and Suspected Transfusion Transmitted Disease (TTD) Report are used to report these adverse events to Memorial Blood Centers. Both forms are available through Memorial Blood Centers’ physicians or their designees in Physician Services. Current examples of both forms are located on pages 43 and 44 of this chapter. Forms can also be found on MBC.ORG/Products-and-Testing-Services under Related Forms & Docs.
Initial notification of a patient/recipient fatality should be reported to the FDA as soon as possible by the facility that performed the compatibility tests. A written report of the investigation shall be submitted to the FDA within seven days after the fatality. Please see FDA Guidance for Industry on pages 48-54.
Immediate notification of the physician on call at Memorial Blood Centers allows review of records and supplies related to donor suitability, collection, processing, storage and distribution of the components.
Rev. June 2015 Quality Assurance • Page 42MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Communications
Customer Service Reports:Memorial Blood Centers strives to provide excellent customer service to each of our customers. We are continuously seeking new ideas for ways to improve or expand the services we provide. We need your assistance to identify the areas where we need improvement as well as the areas where we are meeting or exceeding your expectations. To gather your feedback, Memorial Blood Centers has provided your facility with a supply of Customer Service Reports (CSR). Please complete a CSR any
time a problem is identified or when excellent or poor service is provided to your facility. Please include as much detail as possible so that we can follow-up appropriately.
Every CSR is reviewed by the responsible department manager to determine appropriate action. These events are tracked by the Quality and Regulatory Affairs department to identify opportunities for continuous process improvement.
Rev. June 2015 Quality Assurance • Page 43MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Quality Control (QC) of Blood Components
Memorial Blood Centers performs quality control on components in accordance with the requirements of the AABB and the Food and Drug Administration (FDA). A Blood Component QC Summary will be sent to your facility monthly.
If you have questions about the Blood Component QC Summary, please contact the manager of Component Services at 651-332-7117.
Rev. June 2015 Quality Assurance • Page 44MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Rev. June 2015 Reference Laboratory • Page 45MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Reference Laboratory
Request for Antibody Identification and Red Cell Crossmatching
1. Request products and testing using Memorial Blood Centers Request for Reference Laboratory Testing Form (sample on page 47). Form may be found on MBC’s website at www.mbc.org.
2. Form MUST have patient identification information, hospital name, the test requested and the date and time needed. Specimen requirements are on the reverse side of the form.
3. Samples must meet AABB labeling requirements. Samples for crossmatching MUST have patient’s first and last name, identification number, draw date, and identity of phlebotomist.
4. Please send copies of any red cell panel results and any other information to aid in testing, i.e. list of medications, historical test results, etc.
5. Antibody identification is routinely performed using polyethylene glycol (PEG) as an enhancement media. If an institution indicates a method of testing, we will do the first red cell panel in the same media if available and time permits.
6. Hospitals will receive verbal reports from the technologist upon completion of identification. Final reports are usually available 1-2 business days after completion of testing, and are faxed to the hospital when completed. Preliminary reports can be faxed upon request if the final report is not available.
7. Patient red cell genotyping is available upon request using the Memorial Blood Centers Request for Reference Laboratory Testing Form.
Unit Antigen Typing
1. Antigen typing is performed on all antigen negative units requested between 2:00 am Monday through 11:00 pm Friday. Typed units are identified with a white string tag identifying which antigens have been confirmed as negative. STAT and ASAP requests placed after 11:00 pm and before 7:00 am will incur an additional STAT charge.
2. Local/Metro requests for antigen negative units placed after-hours, 11:00 pm Friday–2:00 am Monday, may be requested by the hospital to be sent out with historical typing. It is the hospital’s responsibility to confirm the antigen type on these units.
3. The Reference Lab will confirm antigen typing on units during after-hours if requested by a hospital to do so. An after-hours service fee will be charged to the hospital for this service.
Antibodies in Donors
When antibodies are detected in autologous donors, the hospital will receive a report stating specificity. The hospital will be charged for the cost of the red cell panels performed on autologous donors. If a hospital prefers to perform the antibody identification, policy must be established prior to donation.
Platelet Crossmatching
Platelet crossmatching and HLA matched platelets may be beneficial to refractory alloimmunized patients with documented lack of response to pooled random donor platelets and/or apheresis platelets.
1. Request products and testing using Memorial Blood Centers Requests for Reference Laboratory Testing Form (sample on page 47). Form may be found on MBC’s website at www.mbc.org.
2. Form must have patient identification information, hospital name, the test requested and the date and time needed.
3. Samples must meet AABB labeling requirements. Samples must have patient’s first and last name, identification number, draw date, and identity of phlebotomist.
4. Platelet crossmatching is performed at 12:00 p.m. Monday-Friday. Requests for crossmatched platelets any other time will incur an additional STAT charge.
Rev. June 2015 Reference Laboratory • Page 46MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
HLA Matched Platelets
1. If patient is refractory to crossmatched patients, HLA matched platelets may be considered.
2. Patient HLA typing shall be requested using Memorial Blood Centers Request for Reference Laboratory Form.
3. Time to procure an HLA matched product for a patient will vary based on HLA type. For donors expecting ongoing transfusions, HLA matched donors will be scheduled as available.
4. If Memorial Blood Centers does not have an adequate match, other blood centers may be contacted at the hospitals request. All charges associated with imported products are passed on to the requesting hospital.
5. Family donations may be considered if HLA matches are not available.
Service Fees
1. Reference Lab has an on-call (AFHRS) and an overnight (STAT) service charge. The on-call charge applies to testing performed Friday 11:00 pm through Sunday 11:00 pm, and on holidays. The STAT service charge applies to testing that must be performed after 11:00 pm and before 7:00 am Sunday through Thursday. This charge also applies to platelet crossmatching performed any time other than 12:00 pm
2. Coverage of weekends and holidays is provided by an on-call technologist. He or she can be reached by contacting Hospital Services (651-332-7108).
3. Requests for units negative for a high frequency antigen or negative for multiple antigens that occur in 5-percent or less of the population are assessed an additional rare (RARE) or phenotyped unit (PHUN) charge respectively.
4. Charges associated with importing rare blood from other blood centers are passed on to the requesting facility.
5. A Platelet Compatibility Charge is applied the first time a patient is tested and after a period of remission or if no crossmatched platelets are ordered. A platelet crossmatch charge is applied to each unit sent; double platelets are charged a single crossmatch fee.
Rev. June 2015 Reference Laboratory • Page 47MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
INSTRUCTIONS: Complete information must accompany each specimen. Identify each sample with patient’s first and last name, identifying number and date drawn ( written in ink ). Improperly labeled specimens will not be processed.
Date_____________________________________________ When needed (date / time)________________________________Hospital / Lab_______________________________________ City________________________________________________State, Zip _________________________________________ Phone ( _____ ) _____________ Fax ( _____ ) ______________
TEST REQUESTED:o Antibody Identification oPlatelet Compatibility o ABO and Rh typing o Crossmatch: o DAT and monospecific AHG Number of units requested _________ o Elution study o Antigen negative unit ( uncrossmatched ): oABO, Rh and antibody screening Number of units requested _________ oHDN evaluation–Mother and baby o Red blood cells ( RBC )oKleihauer-Betke test, type of specimen o Leukocyte-reduced RBC ______________________________________________ o Platelets, Pheresis Reason test ordered _______________________________ oOther, specify ___________________________________oOther (specify) ________________________________________________________________________________________ ___________________________________________________________________________________________________ __________________________________________________________________________________________________ PATIENT INFORMATION:Patient’s name _________________________________________________ Date of birth ______________________ Sex____
Identifying number ______________________________________________ Date / time sample drawn ____________________Clinical diagnosis________________________________________________________________________________________Medications____________________________________________________________________________________________
TRANSFUSION HISTORY: oNo oYes, date of last and quantity ___________________________ oUnavailable
OBSTETRICAL HISTORY: EDC ______________________________________________________________________________Pregnancy oNo oYes, indicate number and date of last _________________________________________________________Has patient received Rh immune globulin in the past 6 months? oNo oYes, date received ________________________________
HISTORY OF PREVIOUS RED CELL ANTIBODY: oNo oYes, specificity ( ies ) ___________________________________________ DESCRIPTION OF REQUESTING FACILITY’S RESULTS:Blood type ______________ DAT ______________ Auto control ______________ FMH screen ________________ Red cell antibody screening (circle phase of reaction, results and method used ) Reaction phase: RT 37C IAT Reaction strength: 1+ 2+ 3+ 4+ microMethod: saline albumin LISS PEG enzyme Gel card Other _____________________________________________Red cell phenotype: C E c e K M N S s Fy ( a b ) Jk ( a b ) Units crossmatched? oYes, Compatible ______________ Incompatible ______________
FORM-RL-001.12 12-07 ( 2-sided document )
Request forReference Laboratory Testing
( Please print ) Last First MI
Quantity Quantity
Lab Phone: ( 651) 332-7125Lab Fax: ( 651) 332-7008
This form should not be used when submitting hepatitis, HIV, HLA typing or parentage samples. Appropriate forms are available from specific laboratories.
SPECIMEN REQUIREMENTS________________________________________________________________________________________________________________________________________________________________________________________ TEST SAMPLE REQUIRED TEST SAMPLE REQUIRED________________________________________________________________________________________________________________________________________________________________________________________
ABO and Rh typing 5-10mL clotted blood Elution study 7-10mL EDTA whole blood________________________________________________________________________________________________________________________________________________________________________________________
Antibody screen / identification, 10-20mL clotted blood** HDN evaluation Mom: 10mL clotted blood Compatibility testing or EDTA whole blood Baby: 2-5mL cord blood (red cell & platelet*) ________________________________________________________________________________________________________________________________________________________________________________________
DAT with monospecific AHG 5-7mL EDTA whole blood Kleihauer-Betke test 5mL EDTA whole blood ________________________________________________________________________________________________________________________________________________________________________________________
NOTE: Gel tubes are unacceptable as they can cause a false positive DAT.
* Platelet crossmatch sample must be submitted within 48 hours of collection.
** If patient has a positive direct antiglobulin test (DAT), include a 7mL EDTA tube. For recently transfused patients, include pretransfusion specimen if available.
All samples referred to Memorial Blood Centers for crossmatching and pretransfusion testing must meet the current Standards of the AABB regarding recipient blood samples. Sender will be notified if a sample is unacceptable; a new sample will be required.
DIRECTIONS FOR SAMPLE TRANSPORTMBC suggests shipping samples at ambient temperature unless temperatures are >82F or <32F.
If ambient temperature is >82F, ship samples with coolant.If ambient temperature is <32F, ship samples in insulated container.
STAFFING HOURSThe Reference Laboratory is fully staffed from 11:00 P.M. Sunday through 11:00 P.M. Friday.
During these hours, contact the lab at (651) 332-7125 or (651) 332-7118. For after-hours requests, call the blood center at (651) 332-7108 and ask for the Reference Lab on-call technologist.
FORM-RL-001.12 12-07 ( 2-sided document )
Request forReference Laboratory Testing
737 Pelham Boulevard • St. Paul, MN 55114Lab Phone ( 651) 332-7125
Lab Fax ( 651) 332-7008
Request for Reference Lab Testing
Rev. June 2015 Guidance for Industry • Page 48MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Guidance for Industry
Guidance for IndustryNotifying FDA of Fatalities Related to
Blood Collection or Transfusion
FINAL GUIDANCE
Additional copies of this guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at http://www.fda.gov/cber/guidelines.htm.
For questions on the content of this guidance contact Lois Simmons at 301-827-6220.
U.S. Department of Health and Human ServicesFood and Drug Administration
Center for Biologics Evaluation and ResearchSeptember 2003
Rev. June 2015 Guidance for Industry • Page 49MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Contains Nonbinding Recommendations
i
Table of Contents
I. PURPOSE.............................................................................................................. 1II. BACKGROUND ................................................................................................... 1
III. HOW TO NOTIFY FDA……………………………………………………….. 2IV. INITIAL NOTIFICATION…………………………………………………….. 2
A. Patient/Recipient Fatalities ...................................................................... 3B. Donor Fatalities......................................................................................... 3C. Fatalities Associated with Therapeutic Apheresis or Certain
Therapeutic Phlebotomies........................................................................ 3V. 7-DAY REPORT................................................................................................... 3
A. Patient/Recipient Fatalities ...................................................................... 4B. Donor Fatalities......................................................................................... 4C. Fatalities Associated with Therapeutic Apheresis or Certain
Therapeutic Phlebotomies........................................................................ 5VI. INQUIRIES ........................................................................................................... 5
Rev. June 2015 Guidance for Industry • Page 50MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Contains Nonbinding Recommendations
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Guidance for Industry
Notifying FDA of Fatalities Related to Blood Collection or Transfusion
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
I. PURPOSE
This document’s goal is to help you, a blood collection or transfusion facility, report fatalities related to blood and blood component (blood) collection or transfusion to us, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title dated June 2002.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.The use of the word should in FDA’s guidances mean that something is suggested or recommended, but not required.
II. BACKGROUND
The current good manufacturing practice (CGMP) regulations for blood and blood components require that you report fatalities related to blood collection or transfusion to CBER (21 CFR606.170(b)). Section 606.170(b) states:
When a complication of blood collection or transfusion is confirmed to be fatal, the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, shall be notified by telephone, facsimile, express mail, or electronically transmitted mail as soon as possible; a written report of the investigation shall be submitted to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, within 7 days after the fatality by the collecting facility in the event of a donor reaction, or by the facility that performed the compatibility tests in the event of a transfusion reaction. (Emphasis added)
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Contains Nonbinding Recommendations
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Standard operating procedures for compatibility testing are required in 21 CFR 606.151 and 606.100(b)(8). Among other things, that regulation requires an establishment to have procedures both for collecting and identifying the blood samples of recipients, and for demonstrating incompatibility between the donor’s cell type and the recipient’s serum or plasma type. CBER is aware that some blood banks and transfusion services may enter into contracts with blood centers or other blood banks or clinical laboratories to perform testing on blood samples. If this is how your facility operates, the responsibility for compatibility testing is shared between the blood bank or transfusion service that collects and identifies the blood sample of the recipient, and the blood center or other blood bank or clinical laboratory that uses procedures to demonstrate incompatibility between the donated blood product and the recipient. If a transfusion-related fatality occurs, both the transfusing facility and the blood center or bank that performed the testing under contract would be responsible for reporting the death to CBER. Under these circumstances, the two facilities may make a joint report under § 606.170(b).
III. HOW TO NOTIFY FDA
Section 606.170(b) states that you may report a fatality by telephone, facsimile, express mail, or electronically transmitted mail (e-mail). We recommend that you submit the initial notification by e-mail, if possible, and if you do so, you will receive an e-mail confirmation receipt from us.If e-mail is not feasible, please notify us by telephone or facsimile. We cannot access notification outside of customary working hours unless you use e-mail or telephone. Similarly, we recommend that you submit 7-day follow up reports by e-mail, facsimile, or express mail.
• E-mail: [email protected]• Telephone/voice-mail number: 301-827-6220• Fax number: 301-827-6748, Attn: CBER Fatality Program Manager • Express mail address:
Office of Compliance and Biologics Quality/CBERAttn: Fatality Program Manager (HFM-650)1401 Rockville Pike, Suite 200NRockville, MD 20852-1448
IV. INITIAL NOTIFICATION
There is no required FDA form or format for notifying us of fatalities related to blood transfusion or blood collection. We recommend that you provide at least the following information so we can evaluate the potential public health significance of the event.
• Date and time of the notification.• Your name, title, telephone number with area code, and fax number (if available).• Your facility's name, mailing address, and FDA registration number (if applicable).
NOTE: Transfusion services that do not routinely collect or process blood or blood components are not required to register with FDA and, therefore, do not usually have a registration number.
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• Age and sex of the deceased.• Date, time, and cause or suspected cause of death (briefly describe what happened).• If an autopsy was or will be performed.• Name and address of facility where the fatality occurred if different from your facility.• Please also include in the initial notification the information listed in A, B, or C below, as
appropriate:
A. Patient/Recipient Fatality- Transfusion date(s),- Blood/blood component(s) and unit number(s) of product(s) that may be
implicated,- Name and address of facility(ies) providing the blood, and- Brief description of events that led to the fatality – include underlying medical
condition or disease and circumstances necessitating this hospitalization, reason for transfusion, how the patient initially responded to the transfusion, any medical intervention taken or response to the reaction, and time from initiating the transfusion to patient’s death.
B. Donor Fatality- Collection date,- What product was collected or attempted to be collected,- Whether this was a manual or automated collection,- If automated, the name and model of collection device and device manufacturer,
and- Brief description of events that led to the fatality – include an overview of the
donor’s previous donations/health history, approximate frequency of donation,any unusual events that occurred during this or any previous donation by the donor, any medical intervention taken or response to the reaction, and time from initiating the blood collection to donor’s death.
C. Fatality Associated with Therapeutic Apheresis or Certain Therapeutic Phlebotomies- Date of therapeutic apheresis (e.g., therapeutic plasma exchange) or therapeutic
phlebotomy,NOTE: A report is required for a therapeutic apheresis fatality only if blood products (e.g., plasma, albumin), rather than products such as crystalloids or hydroxyethyl starch, were given as part of the procedure. A report is required for a therapeutic phlebotomy fatality only if a blood product was collected for manufacture into transfusable biologics.
- Whether product was collected, and the product’s disposition, - Whether this was a manual or automated collection (if automated, include
manufacturer, name, and model of collection device),- If any blood product(s) was transfused, identify the product and the unit or lot
number(s), and- Brief description of events that led to the fatality – include underlying medical
condition or disease and circumstances necessitating the therapeutic apheresis or
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Contains Nonbinding Recommendations
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therapeutic phlebotomy, any medical intervention or response to the reaction,and time from initiating the procedure to patient’s death.
V. 7-DAY REPORT
You must submit a written report of the fatality investigation to CBER within 7 days after the fatality (§ 606.170(b)). We recommend that you identify this report as a follow-up on a fatality notification previously reported to CBER and include the initial notification date. We also recommend that this 7-day report provide any new findings or information relevant to the fatality that have become available since the initial notification, including your follow-up investigation and conclusions.
Section 606.170(a) requires that you conduct a “thorough investigation” of adverse reactions relating to blood collection or transfusion. Section 606.170(b) requires submission of a writtenreport of such investigation within 7 days after an adverse reaction resulting in fatality. We recommend that a “thorough investigation,” and an associated written report for a fatality, include:
• Discharge summary and/or death certificate,• Autopsy report (if performed),• Conclusions and follow-up actions (frequently referred to in the blood community as a
corrective action plan), if appropriate, and • Either A, B, or C listed below, as appropriate.
We understand that, due to the complexity of some fatality investigations, some of this information may not be available when you submit your 7-day report. In that event, you may amend your 7-day report by filing additional information as it becomes available.
A. Patient/Recipient Fatality- Complete transfusion reaction report, including the manufacturer and lot number
of the blood collection system and results of the clerical, serological, and visual re-checks performed.
- Additional relevant documents, include hematology reports; clinical chemistry reports for cardiac and/or liver enzymes, albumin, and bilirubin; viral marker tests; microbiology reports; reports of anti-HLA and/or anti-neutrophil antibody testing; tryptase levels; radiology reports; and physicians’ consults/opinions.
- If replacement fluid(s) was given during the transfusion, indicate which fluid(s) and the unit or lot number(s), and include any other relevant information, manufacturer’s notices, contamination warnings, or replacement fluid recalls.
- If responsibility for the fatality appears to be outside the blood bank, the nurses’ and/or physicians’ notes on the patient, radiology reports, and physicians’ consults/opinions.
- Results of lookback investigation, including follow-up testing on implicated donor(s) when the fatality was the result of transfusion transmitted infectious disease such as hepatitis or HIV.
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Contains Nonbinding Recommendations
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- Meeting minutes or report from your transfusion committee when the fatality was reviewed and discussed. If this incident was reviewed by any other hospital oversight group(s) such as risk management or quality practices, include the report or summary of their findings.
B. Donor Fatality- The deceased’s donor record file that includes the donation just before the fatal
incident and information on all donations during the past 2 years.- Lot numbers and expiration dates of collection sets or harnesses; if replacement
fluid(s) was given during the collection, indicate which fluid(s) and the unit or lot number(s) and include any other relevant information, such as manufacturer’s notices, contamination warnings, or replacement fluid recalls.
- Performance log for the device and any other relevant performance logs, maintenance records, manufacturer’s notices, or recalls on significant machine part(s) on the device/system during the past 2 years.
- If the donor was hospitalized due to the reaction, provide any relevant documents, e.g., reports of laboratory tests, which may help determine the cause of the fatality.
C. Fatality Associated with Therapeutic Apheresis or Certain Thera peuticPhlebotomies- A summary of the deceased’s history of previous therapeutic apheresis or
therapeutic phlebotomy procedures, including any previous adverse reactions related to the procedures.
- Lot numbers and expiration dates of collection sets or harnesses; if replacement fluid(s) was given at any time during the procedure, indicate which fluid(s) and the unit or lot number(s) and include any other relevant information, such as manufacturer’s notices, contamination warnings, or replacement fluid recalls.
- A summary of the performance log for the device and any other relevant performance logs, maintenance records, and manufacturer’s notices or recalls on any significant machine part(s) on the device/system during the past 2 years.
- If the fatality followed therapeutic plasma exchange (TPE) and Fresh Frozen Plasma (FFP) was the replacement fluid, an abbreviated transfusion reaction work-up to rule out ABO incompatibility, bacterial contamination, anaphylactic reaction, or WBC antibody reaction may be useful.
VI. INQUIRIES
If you have any questions about reporting fatalities, please contact the CBER Fatality Program Manager at 301-827-6220.
Rev. June 2015 Guidance for Industry • Page 55MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Qualifications Letter
June 1, 2013
MemorandumTo: Memorial Blood Centers Customers
From: Quality and Regulatory Affairs Department 737 Pelham Boulevard St. Paul, MN 55114
Re: Vendor Qualifications
Memorial Blood Centers is licensed by the Food and Drug Administration (FDA) to manufacture blood and blood components (Establishment License Number 1895) and is regularly inspected by the FDA. Memorial Blood Centers follows the regulations contained in parts 600, 601, 606, 607, 610 and 640 of Title 21 of the Code of Federal Regulations and performs testing according to current Good Manufacturing Practices (cGMPs). Memorial Blood Centers has a quality assurance unit in place, as required by the FDA.
Testing in the Donor Testing Laboratory is performed using FDA-licensed test kits, if such kits are available. Tests are performed and interpreted according to the test-kit manufacturer’s instructions. Donor samples tested for investigational assays are done with prior donor consent and prior approval by an IRB (Institutional Review Board). Testing in the Immunohematology Reference Laboratory is performed using a combination of FDA-licensed reagents and reagents prepared in-house. When FDA-licensed reagents are used, the tests are performed and interpreted according to the manufacturer’s instructions. When reagents are prepared in-house, the FDA requirements for potency, contained in 21 CFR Part 660, are followed. Memorial Blood Centers laboratories are certified by the Centers for Medicare & Medicaid Services (CLIA ID Number 24D0663800).
Memorial Blood Centers is also inspected and accredited by the American Association of Blood Banks (Facility ID Number 6301). Copies of our FDA, AABB, and CLIA certificates are available at MBC.ORG.
If you would like specific information about our quality-control procedures, package inserts for test reagents or Laboratory Medicine SOPs, please do not hesitate to contact QRA at the address above, or by phone at 651-332-7000 or fax at 651-332-7001.
Rev. June 2015 Parentage Testing • Page 56MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Parentage Testing
Amniotic Fluid or Chorionic Villi Sample: If you would like to have testing performed before the child is born, your doctor may perform either an amniocentesis or a chorionic villi sampling. The amniocentesis fluid or the chorionic villi sample can be used to test with buccal cell samples collected from the mother and alleged father to determine parentage prior to birth. Please contact our customer service office for fee schedule and more information.
Umbilical Cord Collection: If you know before the child is born that you would like testing performed, please contact our office. We advise at least a two-week notice to ensure delivery of the collection kit on time. Many hospitals will comply with this request; however, some may elect not to participate. Please discuss this option with the attending Doctor or Midwife before delivery. The mother and alleged father(s) should arrange to have samples collected at our facility or at one of our collection sites.
Buccal Cell Collection: If cord blood is not collected, the child may have a buccal cell collection performed. This procedure involves swabbing the inside of the baby’s cheeks with cotton swabs similar to those used for throat cultures. Blood samples are no longer required for DNA relationship testing.
What type of sample is collected from the individuals tested? Buccal Samples: Four swabs are collected by rubbing two swabs on the inside each cheek for approximately 15 seconds.
Do not drink very hot liquid immediately preceding sample collection.
Blood Samples: Blood samples are no longer required for DNA relationship testing.
How long does the collection take?Completing the forms and collecting the samples takes about 15–30 minutes for the mother and child, and about 15 minutes for the alleged father. You will need to bring identification (preferably a photo id). A photograph and thumbprint will be taken and a consent form must be signed before your samples can be collected.
Common Questions & Answers
Why should you choose Memorial Blood Centers?Memorial Blood Centers (MBC) is one of the oldest, most respected names in parentage testing. We are committed to providing excellent customer service at affordable prices. We have been accredited by the AABB (the national accreditation organization) since 1984. A reputation for reliability and a commitment to education and research have set us apart from our competitors.
How can I start testing for a parentage dispute?Appointments can be scheduled through our customer service office at: (612) 871-6636 or (800) 982-9134
To schedule an appointment, you must have the following information:• Names and birth dates of all parties involved in the
test.• Approximate place, day and time you would like
your appointment to be scheduled.What type of testing is available?Paternity: In matters of paternity, specimens are collected from the Mother, Child and Alleged Father(s). It is possible to perform testing without the mother. Motherless cases may require additional testing time and are assessed a different fee.
Family Studies: Cases to determine maternity and sibling relationships are also available. We can also perform “family reconstruction” testing if an individual is unavailable to be tested. We can do this by testing the individual’s available family members. Please contact our customer service office for fee schedules and more information.
Immigration: Immigration paternity, maternity and family studies are available. Test results can be sent to U.S. Embassies worldwide or to U.S. Citizenship and Immigration Services (USCIS) offices in the U.S. Please contact our customer service office for fee schedules and more information.
At what age are children able to be tested?We are able to collect samples from children prior to birth, at birth or after birth for parentage testing.
Rev. June 2015 Parentage Testing • Page 57MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Is there a difference in accuracy between a blood and buccal swab sample?In an individual, the DNA is the same whether a blood sample or a buccal swab sample is collected and will provide identical results after testing. The reliability of DNA testing is based on obtaining DNA from nucleated cells, not from a specific source. The DNA from an individual will be the same regardless of whether it is extracted from blood or buccal cells. The major difference in the types of sample collection relates to ease of collection, stability of storage and ease of use in the lab. Once the DNA has been extracted, the testing procedures are the same for all sample types.
Are these tests accurate?Yes. A standard test will either exclude the man (say he is not the biological father) or it will say he is more likely to be the father of the tested child with a percentage of at least 99%. Our testing protocol will exclude at least 99% of falsely accused males. DNA testing is the best possible means of resolving parentage issues currently. DNA has been used in courts in the U.S. and around the world.
How long will it take to get results?Maximum turnaround time from the date the last sample is received is 10 business days. Results cannot be given over the telephone. Results are mailed to the representative named or to the address given at the time of sample collection. Changes in representation or requests for additional reports must be received in writing.
Will the child and/or mother need to be re-collected if the first man is excluded?In most cases, we would not need additional samples from either the child or the mother.
Can tests be performed when the parties involved live in different states or countries?Yes. Memorial Blood Center can arrange sample collection nationwide and from many foreign countries. If an individual is having his/her sample collected at a facility other than ours, we will send a collection kit to the appropriate hospital or lab. For individuals living in another country, Memorial Blood Center will send a collection kit to the U.S. Embassy in that country for sample collection.
If an Alleged Father is deceased can paternity testing still be done?Yes. DNA testing can be performed by either testing the deceased individual’s family members or by testing blood or tissue samples taken at the coroner’s office during an autopsy.
Is the accuracy of a DNA test affected by drug use, illness or disease?No. DNA testing is not affected by drug use, illness or disease. DNA testing may be affected if the individual has blood samples collected and has had either a transfusion within 90 days of sample collection or if the individual has had an allogeneic hematopoietic progenitor (HPC) transplant. Buccal swab samples are not affected.
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Memorial Blood CentersParentage Testing Services
Service Fees
Effective January 1, 2008
SERVICES (Relationship Analysis — DNA Testing) FEETesting Kits No Charge
Routine Trios (Mother, Child & Alleged Father)Buccal Cell Sample $450.00 ($150.00/person)
Family Studies (Motherless, Fatherless, Grandparents, Siblings, Y-chromosome, etc.)Buccal Cell Sample $225/person
Special TestingUmbilical Cord Blood Sample $150.00
(must have sample from Mother)Amniotic Fluid Sample $150.00
(must have sample from Mother)Chorionic Villi Sample (CVS) $150.00
(must have sample from Mother)Products of Conception $340.00
(must have sample from Mother)Blood Sample from a Deceased Person $150.00
(if part of a Routine Trio)Blood Sample from a Deceased Person $225.00
(if part of a Family Study)Tissue Sample from a Deceased Person $340.00Twin Testing $150.00/personForensic Studies Consultation required —
please call
Additional FeesExpediting Test Results (5 business days turnaround) $50.00/personImmigration Shipping Fees (International Fed Ex) $140.00 - $210.00
Expert WitnessCourt Testimony $250.00/hour plus expensesDeposition Testimony $200.00/hour plus expenses
Please call 612-871-6636 or 800-982-9134 with questions.
Sample collection fees are not included in the price of the testing if collected outside Memorial Blood Centers. Prices are subject to change without notice.
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Educational Opportunities
Department of Training and EducationThe Training and Education Department is committed to providing valuable, on-going education for our staff, customers, and the community. Please call Memorial Blood Centers and request the appropriate department to take advantage of the following opportunities.
Memorial Blood Centers — Central 651-332-7000Memorial Blood Centers — Duluth 218-723-8080
American Association of Blood Banks (AABB) Audioconferences/ American Society for Clinical Pathology (ASCP) TeleconferencesMemorial Blood Centers — Central and Duluth subscribe to several AABB audioconferences and ASCP teleconferences throughout the year. Our full-service hospitals are invited to attend at no extra charge. Contact Hospital Services in either Central or Duluth to receive notification of upcoming topics or to reserve a seat.
Student RotationsMemorial Blood Centers provides a quality blood bank rotational experience for students in all fields of medicine. These rotations are scheduled on a regular basis. Dependent upon the availability of our staff, we reserve the right to combine groups. Please contact the Training and Education Department well in advance of an anticipated rotation. You will be asked to provide the number of anticipated participants and if possible, a range of acceptable dates.
Facility ToursBehind the scene tours of Memorial Blood Centers facilities and laboratories are offered on a regular basis for medical schools, as well as community groups. School tours are routinely scheduled on the third Tuesday of every month from 9 am to noon. Community groups’ requests are scheduled based on available staffing. Please call the Training and Education Department — Central or Hospital Services — Duluth to register a group.
Volunteer OpportunitiesMemorial Blood Centers is a volunteer-rich community offering a vast array of volunteer opportunities with flexible scheduling to meet people’s interests and availability. Volunteers at Memorial Blood Centers may deliver blood to hospitals, staff blood drives and donor centers, represent the blood center as Ambassadors, or provide both administrative and special event staffing. Volunteers provide excellent customer service, increase Memorial Blood Centers connections to the community, and help save Memorial Blood Centers money. If you or someone you know would like to volunteer or learn more about available opportunities, please contact Volunteer Services at 651-332-7228 or [email protected].
Continuing EducationMemorial Blood Centers’ physicians, technologists, and educators are available to present on a variety of topics. Listed below are several programs currently available through Memorial Blood Centers.
Current Topics and Controversies in Transfusion MedicineMemorial Blood Centers’ physicians are available to our constituents to provide continuing education opportunities on a variety of topics, dependent upon current practices and/or concerns. These topics may include, but are not limited to: Massive Transfusions, Age of Blood, International Transfusion Practices, Pediatric Transfusions, or Transfusion Associated Risks. These are offered by prior arrangement only, so please call Training and Education well in advance of your preferred dates.
Reference Laboratory WorkshopsMemorial Blood Centers’ Reference Laboratory offers an annual workshop experience. Workshops will be presented by Central to both the Cities’ metropolitan area and Duluth — Northland hospitals. Topics will vary and change every year but will be based on hospital blood banking and interesting cases the reference technologists have encountered from partnering hospitals. The Reference Laboratory will send notification when workshops are scheduled.
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School PresentationsMemorial Blood Centers’ staff members are available at either Central or Duluth to present classroom sessions, elementary through college-level, on several science-based themes. Educators are encouraged to call Training and Education to schedule these presentations. Memorial Blood Centers’ staff will visit the site and provide all necessary materials. A popular presentation is “Blood 101.” This session helps young people understand blood components and their uses, helps them see the importance for blood transfusions, and recognize how they can help their communities through donating blood.
“My Blood, Your Blood”This educational program is designed for both elementary and secondary students. A DVD and curriculum are provided that introduce students to the human circulatory system. The program was created for America’s Blood Centers by a national team of scientists, physicians, and educators. It teaches students the importance of our blood and blood donation. Please call the Training and Education Department to request this program.
Technical Advisory Meeting (TAM)Memorial Blood Centers hosts meetings for our customers’ blood bank supervisors or designees. These meetings are sponsored by Central for Twin Cities’ metropolitan area hospitals and by Duluth for Northland affiliates. Northland meetings are all-day events in order to accommodate out-of-town attendees. TAMs are linked, at least twice a year, to an AABB audioconference. Hospitals are encouraged to submit agenda items.
Agenda items may include:• Presentations on current topics in blood banking• Announcements and discussions of upcoming
changes at Memorial Blood Centers• Components• Other related services• Quality monitors• Hospital-led, round table discussionsIf interested but unable to attend, summary notes and handouts are generally available upon request. Please contact Hospital Services — Central or Duluth.
Medical Advisory CouncilPhysicians supervising the Transfusion Services supported by Memorial Blood Centers are invited to participate in meetings to provide input and feedback to Memorial Blood Centers on topics related to patient safety and product availability. These meetings will occur once or twice a year and hospitals will be notified when they are scheduled.
Test Name Test Codes CPT Code Lab Sample Requirements Storage & Shipping Requirements
Methodology & Reflex Testing TAT Days Set Up
ABO/Rh Typingac MTYPE/TYPE 8690086901
RL 5-10mL clotted blood (preferred) 5-10mL EDTA
Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, written report in 5 days.2
24 hours a day, 7 days a week
Absorption3bc ABS 86978 RL 10-20mL clotted blood and 7mL EDTA or 14-20mL EDTA whole blood
Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Antibody Identificationbcf IDDN/IDDP 86900869018688086870
RL 10-20mL clotted blood and 7mL EDTA or 14-20mL EDTA whole blood
Keep from extreme heat or cold. Hemagglutination tube or Gel card. Sample may require separation techniques. Depending on results, additional methods such as adsorption, elution, titration may be performed.
Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Antibody Screening bc ABY 86850 RL Serum or Plasma (EDTA, ACD, CPD, CPDA-1, and CP2D) 200 μl minimum volume.
Keep from extreme heat or cold. Hemagglutination tube or Gel card. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Antibody screening plus blood typeabc SCR 86900 86901 86850
RL 10ml clotted blood or 5ml EDTA Keep from extreme heat or cold. Hemagglutination tube or Gel card; if positive, antibody identification performed.
Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Crossmatch-Red Cellabc XM 86920 86921 86922
RL 10-20 ml clotted blood and 7ml EDTA or 14-20ml EDTA whole blood
Keep from extreme heat or cold. Hemagglutination tube testing; antigen negative units provided for patients with clinically significant antibodies.
Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
DAT Battery (Direct Antiglobulin Test)cf DAT 86880 x3 RL 5-7ml EDTA whole blood. Keep from extreme heat or cold. Hemagglutination tube testing using polyspecific, IgG, and C3 anti-human globulin.
Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Donath-Landsteiner Test D-L 86940 86941
RL Contact Reference Laboratory if ordering this test.
Hemagglutination. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Drug Studybc DRUG 86975 RL Contact Reference Laboratory if ordering this test.
Varies by drug being studied. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Elutionbc ELU 86860 RL 7-10 ml EDTA whole blood. Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
HDN Evaluation, includes: ABO/Rh, DAT on cord blood, elution on DAT positive cord blood, antibody screening and identification on mother's blood.abc
(varies) 86900 8690186880 86860 86850
RL Mom: 10ml clotted blood or EDTA.
Baby: 2-5ml EDTA cord blood.
Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
HLA Matched Platelet HLA 99090 RL Contact Reference Laboratory if ordering this product.
NA NA Varies.2 24 hours a day, 7 days a week
Lectin Panel (Polyagglutination test)d PHEN 86999 RL 5-10mL clotted blood or 7mL EDTA whole blood.
Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Kleihauer-Betkee KB 85460 RL 5ml EDTA peripheral blood, amniotic fluid, vaginal blood/blood smears
Keep from extreme heat or cold. In-house acid elution method. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
PLA1 Negative Platelet PLA1 99090 RL Contact Reference Laboratory if ordering this product.
NA NA Varies.2 24 hours a day, 7 days a week
Platelet Compatibility Panelh PLCT 86022 RL 10 ml clotted blood or EDTA, less then 48 hours old.
Keep from extreme heat or cold. Solid phase. Verbal report in 8 hours, written report in 5 days.
Monday-Friday 12 p.m. 1
Platelet Crossmatchh PLXM 86022 RL 10 ml clotted blood or EDTA, less then 48 hours old.
Keep from extreme heat or cold. Solid phase. Verbal report in 8 hours, written report in 5 days.
Monday-Friday 12 p.m. 1
Red Cell Phenotyping (patient antigen typing)ac PHEN 86905 RL 7-10ml EDTA whole blood. Keep from extreme heat or cold. Hemagglutination tube. Depending on results, may require cell seperation and/or chemical treatment.
Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Rh Extended Phenotypingac RH 86906 RL 7-10ml EDTA whole blood. Keep from extreme heat or cold. Hemagglutination tube. Depending on results, may require cell seperation and/or chemical treatment.
Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Sickle Cell Test (Hemoglobin S)g SQ 85660 RL 5-10 ml clotted blood EDTA Keep from extreme heat or cold. Solubility Method. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Stroma Absorptionbc SABSS/ SABST
86978 RL 10-20mL clotted blood and 7mL EDTA or 14-20mL EDTA whole blood
Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Testing Services
Testing Services • Page 1Rev. June 2013 MBC.ORG © 2013 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Test Name Test Codes CPT Code Lab Sample Requirements Storage & Shipping Requirements
Methodology & Reflex Testing TAT Days Set Up
Titrationbc TITR 86886 RL 10 ml clotted blood or EDTA Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Transfusion Reaction Workup
Includes: ABO/Rh on pre, post and donor sample; DAT on pre and post; antibody screening and identification on pre and post sample, elution on DAT positive samples. Other testing as indicated.abc
(varies) 86078 86900 86901 86880 86922 86850
RL Pre and Post Sample 10-20ml clotted blood and EDTA.
Segments from implicated donor units
Keep from extreme heat or cold. Hemagglutination tube. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Unit Antigen Screenabc USCR 86902 RL NA NA Hemagglutination tube. As requested.2 24 hours a day, 7 days a week
Unit Antigen Typingac AGN 86902 RL NA NA Hemagglutination tube. If unable to type historical antigen negative, may reflex to unit antigen screening.
As requested.2 24 hours a day, 7 days a week
Unit Screening with Patient Serumbc XSCR RL 10-20 ml clotted blood and 7ml EDTA or 14-20ml EDTA whole blood
Keep from extreme heat or cold. Hemagglutination tube or Gel card. Verbal report in 8 hours, written report in 5 days.
24 hours a day, 7 days a week
Testing Services • Page 2Rev. June 2013 MBC.ORG © 2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Interference with Testing
Test Reagents
a (antigen, abo) antibodies, reagent cells Recent transfusion, red cells coated with immunoglobulins, polyagglutination, strong cold autoantibodies, and rouleaux may interfere with testing.
b (ID, screen, XM,) reagent panels, PEG, LISS, GEL, Alb, High levels of serum globulins, rouleaux, hemolysis, grossly icteric samples, and grossly lipemic samples may interfere with testing. Complement binding antibodies may not be detected using plasma.
c (DAT, indirect antigen) IgG C3 PS CC Various drugs and certain disease states may interfere with testing.
d (polyagglutination) Lectin panel Bacteremia may interfere with testing.
e (K-B) Disease states that cause retention of fetal hemoglobin or other abnormal hemoglobin's may interfere with testing.
f (DAT only) Cold antibodies may attach to complement in clotted samples and interfere with testing.
g (SQ) Severe anemia, persistence of fetal hemoglobin, polycythemia, multiple myeloma, cryoglobulinemia, and other dysglobulinemia may interfere with testing.
h (platelet) ABH antibodies and isoagglutinins may interfere with testing.
1 This test only occurs at 12:00 PM, Monday - Friday. Please contact Reference Laboratory for STAT requests, which may incur an additional charge.
2 Ordering a test STAT may reduce turn around time. STAT requests may incur an additional charge.
3 Absorption is a reflex test performed when antibody identification reveals an autoantibody or during absorption elution testing.
Rev. June 2015 Thank you • Page 62MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Thank youWe exist to serve the community.
Rev. June 2015 Addendum • Page 63MBC.ORG ©2015 Memorial Blood Centers. Confidential and Proprietary. All rights reserved.
Addendum
Special Collections Memorial Blood Centers collects and processes the Special Collections listed in this section. The process for ordering each type of special collection is described below.
Autologous Collection A collection that is intended solely for the donor.
Ordering: The ordering physician completes and signs Physician Order For Autologous Blood Donation (Form-DC-032).
• Fax or mail a copy of the completed order form to MBC
• Give the original form to the donor/patient A MBC staff member will contact the donor/patient to schedule an appointment.
Directed Collection A collection that is intended for a specific patient, but may be crossed over for allogeneic transfusion. The donor must meet all allogeneic donation criteria.
Ordering: The Request for Directed Donation form is initiated by the ordering physician (Form-DC-078).
• Complete all three sections: ◆ Section I – Ordering Physician ◆ Section II – Patient ◆ Sections III – Transfusion Service
• Fax the completed form to MBC The donor must contact MBC to schedule an appointment.
Note: If ABO/Rh identical units only is marked on the order form, only donations that are ABO and Rh identical will be distributed to the transfusion service.
If ABO/Rh identical units only is not marked, all compatible collections will be distributed to the transfusion service.
Frequent (Dedicated) Directed Collection A collection that is intended for and used solely by a single identified recipient.
Ordering: The patient’s physician contacts a MBC physician to initiate a frequent (dedicated) directed collection.
• After consulting with a MBC physician, if collection is approved, the ordering physician completes and faxes Request for Frequent (Dedicated) Directed Donation (Form-PS-126) to MBC.
A MBC staff member will contact the donor to schedule an appointment.
Therapeutic Collection
Ordering: The patient’s physician completes the Physician’s Order Form for Therapeutic Phlebotomy (Form-DC-025).
• Fax the completed order form to MBC• Give the original form to the donor/patient
The donor/patient must call MBC to schedule an appointment.
Added: August 2011